Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617111

FEI Number

3006442872

Entity Name

SPS Medical

City/State/Country

COULOMMIERS Seine-et-Marne, FR

Establishment Address

5, rue de Montigny, Zone Industrielle, COULOMMIERS Seine-et-Marne 77120, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SPS Medical (Owner Number: 8020678)

Owner / Operator Contact Address

5, rue de Montigny, Zone Industrielle, COULOMMIERS, FR-77 77120, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ADVANCE STERILIZATION PRODUCTS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2020-12-18
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2020-12-18

Official Correspondent

Nathalie MARCHAND

US Agent Details

Celena Frazier Business: Sterimed Inc. Email: quality@sterimed.us Phone: (843) 3888080

Related Public Records

Same Entity

SPS Medical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11
K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

Similar Registrations

Registration Number	Establishment Name	Location
3007412809	STERIS Corporation	FRANKLIN PARK, IL, US
2410251	PROPPER MFG. CO., INC.	Long Island City, NY, US
3009968482	HU-FRIEDY MFG CO., LLC	Des Plaines, IL, US
3013298431	VEENAK INTERNATIONAL LIMITED	BIRMINGHAM, GB
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617111. Last updated year: 2026. Please use registration number 9617111 when referencing this establishment in official correspondence.