Medical Device Establishments Registered with FDA as Contract Sterilizers (Worldwide)
576 medical device establishments in 50 countries (153 in the U.S. incl. Puerto Rico, 423 elsewhere), one row per facility (FEI number), that are registered with FDA (registration expiry year 2026) and declare the establishment type 'Contract Sterilizer' (sterilizes medical devices for another party) on at least one of their device listings; they belong to 423 owner/operators. The type is self-declared. ReqoData judges 204 rows to be sterilization/irradiation service businesses, 331 rows to be device manufacturers, contract manufacturers or other businesses, and 41 rows Unclear. For 214 rows (the 204 Y rows, 8 N/Unclear rows that an outside list named as contract sterilizers, and 2 other rows of the same owner/operators) ReqoData checked operators' websites and other public pages on 2026-10-07: for 159 rows a cited page states that the operator sterilizes products for customers (offers_contract_sterilization Y), 55 are Unclear. Sterilization methods are given for 178 rows (160 from those pages, 18 U.S. rows as EtO from EPA's list). Built from FDA's weekly download files dated 2026-10-05; checked 2026-10-06.
Data Preview
* The first 5 rows of the full list (real data).| facility_name | fei_number | registration_number | address | city | state_province |
|---|---|---|---|---|---|
| ADVANCED PRODUCT SOLUTIONS, INC. | 3038252365 | 3038252365 | 502 W Church St | Columbia | AL |
| Sterigenics US LLC | 3002907620 | 3002907620 | 1700 College Blvd. | West Memphis | AR |
| Stryker Sustainability Solutions Phoenix | 3002615969 | 2090040 | 10232 S. 51st St. | Phoenix | AZ |
| Becton Dickinson Tuscon | 3045322464 | 3045322464 | 7345 E Valencia Rd | Tucson | AZ |
| Sterility Assurance Laboratories, Inc. | 3003337383 | 2087200 | 2420 N. Huachuca Dr. | Tucson | AZ |
Showing 6 of 24 columns. All columns are listed below.
Full list: 576 rows · CSV · last verified Oct 6, 2026
* One-time payment via Stripe · Organization info only · No change-of-mind refunds (digital product)
Where the source data is published
FDA publishes the facility records in this list free of charge: the Establishment Registration and Medical Device Listing download files (https://www.fda.gov/medical-devices/device-registration-and-listing/establishment-registration-and-medical-device-listing-files-download; files at https://www.accessdata.fda.gov/premarket/ftparea/, updated every Sunday night) and the openFDA device registration API (https://open.fda.gov/apis/device/registrationlisting/). EPA's list of ethylene oxide commercial sterilization facilities, used for one column, is also free (https://19january2025snapshot.epa.gov/hazardous-air-pollutants-ethylene-oxide/ethylene-oxide-commercial-sterilization-facilities). FDA and EPA data are U.S. Government works in the public domain (17 U.S.C. 105), and openFDA data is released under CC0 1.0. ReqoData selected, joined and normalized these records and added the columns described above. This list is not produced, endorsed or certified by FDA or EPA.
Read the full noteAbout this list
- Rows
- 576
- Columns
- 24
- Format
- CSV (UTF-8, opens in Excel)
- Last verified
- Oct 6, 2026
Source data as of
FDA establishment registration and device listing download files dated 2026-10-05; EPA ethylene oxide commercial sterilizer list last updated 2024-05-16; operators' websites and other cited pages reviewed 2026-10-07
Last verified is the date we fetched the source data and confirmed it was the latest version the publishers had released.
What this list adds to the free source data
- Selected, from FDA's weekly registration files covering all registered device establishments, the 577 establishments whose device listings carry the Contract Sterilizer type, and joined FDA's facility, owner/operator and establishment-type files into one row per facility (FEI number).
- Excluded 1 sole proprietorship named after a person, and left out FDA's U.S. agent, official correspondent and contact-person records, so every row describes an organization.
- Added dedicated_sterilization_provider (Y/N/Unclear) with dedicated_basis: ReqoData's judgment, made per owner/operator, of whether the business is a sterilization/irradiation service company (Y 204 rows, N 331, Unclear 41). 38 owner/operators were reviewed by hand; the others follow fixed rules on FDA establishment types and names (see the column description). This is not FDA data.
- Added offers_contract_sterilization (with the cited page and a short basis) for 214 rows: the 204 Y rows, 8 N/Unclear rows that an outside list named as contract sterilizers, and 2 other rows of the same owner/operators. Y (159 rows, 53 owner/operators) means the cited page states that the operator sterilizes products for customers; for multi-site groups (e.g. Sterigenics, STERIS AST, Ionisos, BGS) it is the group's page for the site matched to this facility, by street address where the page gives one and otherwise by town, state, ZIP code or country as the row's basis says (the 6 Ionisos rows, Sterigenics Hidalgo and STERIS Vega Alta). The pages are the operators' or their groups' websites, except an International Irradiation Association announcement (Sor-Van) for 1 row; a Malaysian Investment Development Authority article (KHTP Sterilisation Services) for 1 row; a company press release (E-BEAM Services) for 2 rows. 3 of the Y rows are not judged dedicated providers (contract manufacturers that also run a sterilization service). The other 55 reviewed rows are Unclear. Every cited page except 2 is re-fetched at build time and the build fails if a cited phrase is missing.
- Added sterilization_methods with its source for 178 rows: 160 rows from the pages cited for the site (or for the company where it names a single method), and 18 U.S. rows as EtO because the site is on EPA's list of ethylene oxide commercial sterilization facilities.
- Added epa_eto_commercial_sterilizer_listed for U.S. sites by matching street number, street name and city against EPA's list of ethylene oxide commercial sterilization facilities (86 entries, page last updated May 16, 2024, read from EPA's January 2025 web snapshot because the page is no longer on www.epa.gov): 43 of 153 U.S. rows matched, 3 of them matched by hand where FDA and EPA write the city or street number differently.
- Added company_website for 108 of 423 owner/operators (242 rows). Each site passed an automated check (robots.txt allows access, HTTP 200, not a parked domain, the company's or its parent group's name on the page); an independent manual re-check of all sites removed 2 that belonged to other businesses.
- Normalized addresses: for non-U.S. sites the province is split from FDA's combined city field only when it matches one of FDA's own province values; ALL-CAPS city names are title-cased; 12 placeholder postal codes (such as '--' or '00000') are left empty; 1 province value that contradicted its address was removed (FEI 3006089143: 'Xinjiang' on an address in North Point, Hong Kong).
- Cross-checked the facility set against openFDA (data last updated 2026-09-28), which returns 578 FEIs for the same establishment type; the difference is FEI 1121091: Manus Medical, LLC is still registered in FDA's 2026-10-05 Registration file (registration expiry 2026), but none of its device listings there carries the Contract Sterilizer type any more; its listings show only Manufacturer, Repackager/Relabeler, so it is not included. Added a per-row openFDA query URL (source_url) for checking each record at the source.
Limitations and what's not included
- FDA registration and the 'Contract Sterilizer' establishment type are self-declared by the registrant. Registration does not denote FDA approval of the establishment or its products (21 CFR 807.39), and it is not a clearance or certification either.
- Most rows are not dedicated sterilization service companies: 331 rows are judged device manufacturers, contract manufacturers or other businesses (such as testing laboratories), and 41 rows are Unclear. The judgment is ReqoData's, made per owner/operator from FDA establishment types, names and a manual review of 38 owner/operators, and can be wrong for an individual site.
- offers_contract_sterilization was checked only for 214 rows (the 204 Y rows, 8 N/Unclear rows that an outside list named as contract sterilizers, and 2 other rows of the same owner/operators) and is empty for the other 362 rows. Unclear (55 rows) = no current page was found that states the operator sterilizes products for customers at this site; it does not mean the site does not offer it. 4 Unclear rows still cite a page, as their basis says: for 3 the page names the company or its sterilization but does not state a service for customers at this site (Parter Ontario FEI 3005735987, Terumo BCT Lakewood FEI 3003094851, Steri-Tech FEI 2648209), and for Greenpia Technology (FEI 3002807112) it is a March 2016 news article that states a gamma sterilization service for medical devices; no current source was found for it. For most Unclear rows in China and several elsewhere in Asia, no company website was found. No row is N. Y rests on the cited page as read on 2026-10-07; where a company with several facilities in this list does not distinguish them, the statement covers all of them. Whether a site accepts a given customer or product is not checked.
- sterilization_methods is filled for 178 of 576 rows and lists only the methods the cited source names for the site (for companies that name a single method, that method); empty means not found, not that no method is used. Methods for 18 U.S. rows come only from EPA's EtO list, so other methods used at those sites are not shown. Capacity, ISO certification and validation services are not included.
- epa_eto_commercial_sterilizer_listed only shows whether a U.S. site's address appears on EPA's 86-entry list last updated May 16, 2024. N does not mean the site does not use ethylene oxide; non-U.S. rows are N/A.
- Only establishments registered with FDA are included (in general, those connected with devices for the U.S. market); sterilization sites without an FDA registration are not.
- No contact persons, personal names, email addresses or phone numbers. company_website is filled for 242 of 576 rows; empty means no site was verified, not that none exists.
- Addresses are reproduced as registrants entered them in FDA's system and can contain errors (for example, some Hong Kong addresses are recorded with country China); apart from FEI 3006089143, they are not corrected. The owner/operator can be a parent company, so its name can differ from the facility name.
- Snapshot of FDA's files dated 2026-10-05. FDA updates the files weekly; registrations and establishment types that changed after that date are not reflected.
- 45 postal codes start with 0; spreadsheet programs can drop the leading 0 when the CSV is opened directly, so import that column as text.
Where the source data is published
FDA publishes the facility records in this list free of charge: the Establishment Registration and Medical Device Listing download files (https://www.fda.gov/medical-devices/device-registration-and-listing/establishment-registration-and-medical-device-listing-files-download; files at https://www.accessdata.fda.gov/premarket/ftparea/, updated every Sunday night) and the openFDA device registration API (https://open.fda.gov/apis/device/registrationlisting/). EPA's list of ethylene oxide commercial sterilization facilities, used for one column, is also free (https://19january2025snapshot.epa.gov/hazardous-air-pollutants-ethylene-oxide/ethylene-oxide-commercial-sterilization-facilities). FDA and EPA data are U.S. Government works in the public domain (17 U.S.C. 105), and openFDA data is released under CC0 1.0. ReqoData selected, joined and normalized these records and added the columns described above. This list is not produced, endorsed or certified by FDA or EPA.
Organization info only. The list contains no personal contact details of individuals.
Columns in the CSV (24)
| Column | Description |
|---|---|
| facility_name | Establishment name as registered with FDA (whitespace collapsed). |
| fei_number | FDA Establishment Identifier (FEI) of the facility. One row per FEI. |
| registration_number | FDA establishment registration number. |
| address | Street address lines from FDA's facility record, as the registrant entered them. |
| city | City from FDA's facility record; ALL-CAPS names are title-cased. For non-U.S. sites it can also hold the province when the province could not be split off. |
| state_province | U.S. state code. For non-U.S. sites, the province split from FDA's combined city field only when it equals one of FDA's own province values for that country; otherwise empty. |
| postal_code | Postal code from FDA's facility record; placeholders such as '--' or '00000' are left empty. Import as text to keep leading zeros. |
| country | Country name for the ISO country code FDA records (FDA records some Hong Kong addresses as China). |
| country_code | ISO 3166-1 alpha-2 country code as recorded by FDA. |
| owner_operator_name | Firm FDA records as owner or operator of the establishment (can be a parent company). |
| owner_operator_number | FDA owner/operator number. |
| fda_establishment_types | All establishment types on the facility's device listings in FDA's files (self-declared), Contract Sterilizer first. |
| dedicated_sterilization_provider | ReqoData's judgment, not FDA data, made per owner/operator: Y = sterilization/irradiation service business; N = device manufacturer, contract manufacturer or other business; Unclear = not decidable. 38 owner/operators were reviewed by hand. The others follow these rules in order, using all of the owner/operator's establishments in this list: (1) an own-device type is declared (Manufacturer, Remanufacturer, Reprocessor of Single Use Devices, Specification Developer, Complaint File Establishment or Foreign Private Label Distributor) -> N; (2) the owner/operator or facility name contains a sterilization/irradiation keyword (steriliz-/sterilis- (also inside a word, e.g. Spanish esteriliz-), steril/sterile, irradiat- (also the misspellings irridiat- and lrradiat-), radiation, e-beam/electron beam, gamma, ethylene oxide, disinfection, isotope, nuclear, or one of these company-name terms: Sterigenics, STERIS, Isomedix, Synergy Health, Ionisos, NextBeam, Medistri, Sterico, Steritec (incl. Steritech), Sterlab, Sterox, ProSteri, SteriEO (e.g. SteriEOSS), Steriservice(s), Steri Services, Steri Solutions, or 'Steri-' (e.g. Steri-Tek)) -> Y; (3) Contract Manufacturer or Repackager/Relabeler is declared -> N; (4) otherwise Unclear. U.S. Manufacturer of Export Only Devices and Foreign Exporter are not counted: sterilization service companies (e.g. Sterigenics and STERIS Isomedix sites) also declare the former, and FDA defines the latter as performing no other operation on the device. |
| dedicated_basis | The manual review note or rule that set dedicated_sterilization_provider. It describes the owner/operator, so a type it names can be declared at another establishment of the same owner/operator in this list rather than at this row. Rule-based values also name U.S. Manufacturer of Export Only Devices and Foreign Exporter where the owner/operator declares them; manual review notes do not. |
| offers_contract_sterilization | ReqoData's review (2026-10-07), not FDA data. Y = the page cited in offers_contract_sterilization_source states that the operator sterilizes products for customers; for groups with several sites, the group's page for the site matched to this facility, by street address where the page gives one and otherwise by town, state, ZIP code or country as offers_contract_sterilization_basis says. The pages are the operators' or their groups' websites, except an International Irradiation Association announcement (Sor-Van) for 1 row; a Malaysian Investment Development Authority article (KHTP Sterilisation Services) for 1 row; a company press release (E-BEAM Services) for 2 rows. Unclear (55 rows) = no current page was found that states the operator sterilizes products for customers at this site; it does not mean the site does not offer it. 4 Unclear rows still cite a page, as their basis says: for 3 the page names the company or its sterilization but does not state a service for customers at this site (Parter Ontario FEI 3005735987, Terumo BCT Lakewood FEI 3003094851, Steri-Tech FEI 2648209), and for Greenpia Technology (FEI 3002807112) it is a March 2016 news article that states a gamma sterilization service for medical devices; no current source was found for it. N is not used. Empty = not reviewed: only 214 rows were reviewed (the 204 Y rows, 8 N/Unclear rows that an outside list named as contract sterilizers, and 2 other rows of the same owner/operators). |
| offers_contract_sterilization_basis | Short description of what the cited page says (or why the row is Unclear). |
| offers_contract_sterilization_source | URL of the page behind offers_contract_sterilization; empty for Unclear rows where no page was found. |
| sterilization_methods | Sterilization methods the cited source names for this site, separated by '; ', from: EtO, propylene oxide, gamma, e-beam, X-ray, steam, dry heat, VHP, hydrogen peroxide gas plasma (EtO = ethylene oxide, VHP = vaporized hydrogen peroxide). For a company that names a single method for all its sites, that method. Where a company names several methods without saying which are performed at the site and states only some as run in-house, only those (1 row, Eagle Medical). U.S. sites on EPA's list of ethylene oxide commercial sterilization facilities that the review gave no method get EtO with EPA's list as the source. Empty = no source found; nothing is inferred. |
| sterilization_methods_source | URL(s) of the page(s) behind sterilization_methods, separated by ' ; '. |
| epa_eto_commercial_sterilizer_listed | U.S. rows: Y when the site's street number, street name and city match an entry on EPA's list of ethylene oxide commercial sterilization facilities (86 entries, last updated May 16, 2024; 3 matched by hand where FDA and EPA write the city or street number differently); N when there is no match, which is not a statement about the sterilization method. Non-U.S. rows: N/A. |
| registration_expiry_year | Expiry year of the FDA registration as recorded in FDA's file. |
| company_website | Website of the owner/operator or its parent group, filled only when it passed the automated check; all filled sites were also re-checked by hand. Empty means not verified. |
| source_url | openFDA API query for the row's FEI number, for checking the record at the source (openFDA data last updated 2026-09-28, about a week behind FDA's files). |
| last_verified | Date ReqoData last checked this row against FDA's files. |
Sources and licenses
- U.S. FDA - Establishment Registration and Medical Device Listing Files for Download (page)U.S. Government work, public domain (17 U.S.C. 105)
- U.S. FDA - Registration.zip / listing_estabtypes.zip / estabtypes.zip / Owner_Operator.zip / contact_addresses.zip (registration, listing, owner/operator and contact address files dated 2026-10-05)U.S. Government work, public domain (17 U.S.C. 105)
- openFDA device/registrationlisting API (per-row source_url and count cross-check)CC0 1.0 / public domain (https://open.fda.gov/license/)
- U.S. EPA - Ethylene Oxide Commercial Sterilization Facilities (page last updated May 16, 2024; read from EPA's official 19 January 2025 web snapshot because the page is no longer on www.epa.gov)U.S. Government work, public domain (17 U.S.C. 105)
- Operators' own websites and the other pages cited per row in offers_contract_sterilization_source and sterilization_methods_source (reviewed 2026-10-07)Cited for facts only (whether a service is offered, which methods, at which address); no page content is redistributed beyond short identifying phrases
Last verified: Oct 6, 2026
Frequently Asked Questions
Q.Where does the data come from?
Mainly from the official registers and other public data listed on this page under “Sources and licenses”. For some lists, ReqoData added columns (such as website URLs) after checking each organization's own website; those sources are listed there too. Organization info only — no personal contact details.
Q.Is the full list available now?
Yes. After payment you get the CSV (576 rows, last verified Oct 6, 2026) on a download page right away.
Q.What does it cost?
$149, a one-time card payment through Stripe. There is no subscription. As a digital product, it can't be returned for change of mind; if the file has a material error, report it from the download page and we'll provide a corrected file or a refund.
Q.Is the list updated after purchase?
No. The CSV reflects the sources as of FDA establishment registration and device listing download files dated 2026-10-05; EPA ethylene oxide commercial sterilizer list last updated 2024-05-16; operators' websites and other cited pages reviewed 2026-10-07; on Oct 6, 2026 (last verified) we confirmed these were the latest versions published. It isn't updated automatically, and there is no API. If you download it again later, you get the version of this list we provide at that time.
Q.What format is it delivered in?
CSV (opens in Excel or Google Sheets). There is no API.