Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002808468

FEI Number

3002808468

Entity Name

SAP

City/State/Country

Saint Saulve Hauts-de-France, FR

Establishment Address

14 Rue des Fontaines, Saint Saulve Hauts-de-France 59880, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VYGON S A (Owner Number: 8020785)

Owner / Operator Contact Address

5-11 RUE ADELINE, --, ECOUEN, FR-NOTA 95440, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K851477

PMA Number

N/A

All Registered Proprietary Names

Vygon Exchange Transfusion Tray 275.xxx

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BRZ	Set, Blood Transfusion	General Hospital	Class 2	880.5440	2015-01-08

Official Correspondent

Chris Steinke

US Agent Details

Chris Steinke Business: Vygon USA Email: csteinke@vygon.com Phone: (603) 7435988

Related Public Records

Same Entity

VYGON S A

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009291251	SIPV	Ecouen Ile-de-France, FR
3002808466	SIPA	Avesnes Sur Helpe Hauts-de-France, FR
3014663754	Vygon Portugal	Balter-Paredes Porto, PT
9612433	VYGON Germany GmbH	AACHEN North Rhine-Westphalia, DE
3002808467	Dimequip	Frameries Hainaut, BE

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3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
1319639	Sterigenics U.S., LLC	Queensbury, NY, US
8020785	VYGON S A	ECOUEN 95440 Val-d'Oise, FR
2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002808468. Last updated year: 2026. Please use registration number 3002808468 when referencing this establishment in official correspondence.