Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616277

FEI Number

3003244997

Entity Name

S.M.A.D.

City/State/Country

L'ARBRESLE Rhone, FR

Establishment Address

Z.I. DE LA PONCHONNIERE, ROUTE DE LA CHANADE, L'ARBRESLE Rhone F-69210, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FRESENIUS MEDICAL CARE (Owner Number: 8010838)

Owner / Operator Contact Address

ELSE KROENER-STRASSE 1, --, BAD HOMBURG, DE-HE D-61352, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

bibag

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2018-06-28

Official Correspondent

No official correspondent registered.

US Agent Details

DENISE OPPERMANN Business: Vice President Regulatory Affairs NA Email: denise.m.oppermann@freseniusmedicalcare.com Phone: (781) 9969103

Related Public Records

Same Entity

FRESENIUS MEDICAL CARE

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9611824	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	SCHWEINFURT Bavaria, DE
3043014136	GXO Logistics H France	Andrezieux-Boutheon Loire, FR
3035708507	Pabst Transport GmbH & Co. KG	Gochsheim Bavaria, DE
9611823	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	ST. WENDEL Saarland, DE
3016096143	TST GmbH	Gernsheim Hesse, DE

Similar Registrations

Registration Number	Establishment Name	Location
2431908	EDLAW PHARMACEUTICALS, INC.	E Farmingdale, NY, US
3027241826	RENAL CARE DIALYSIS SOLUTIONS, S.A. DE C.V.	El Marques Queretaro, MX
1225714	Fresenius Medical Care Renal Therapies Group, LLC	Waltham, MA, US
1528807	Nipro Renal Solutions USA, Corporation	LEWISBERRY, PA, US
8030639	BAXTER S.A. DE C.V.	CIVAC, JIUTEPEC, MORELOS, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616277. Last updated year: 2026. Please use registration number 9616277 when referencing this establishment in official correspondence.