Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012319642

FEI Number

3012319642

Entity Name

BIT Group France

City/State/Country

Mauguio Herault, FR

Establishment Address

195 Avenue Margot Duhalde, Mauguio Herault 34130, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BIT Group France (Owner Number: 10024699)

Owner / Operator Contact Address

Parc Euromedecine II, Montpellier Cedex 5, FR-OCC FR-34099, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2015-11-23

Official Correspondent

No official correspondent registered.

US Agent Details

WILLIAM MCLAIN Business: Keystone Regulatory Services, LLC Email: bill.mclain@keystoneregulatory.com Phone: (717) 6569656

Related Public Records

Same Entity

BIT Group France

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006946274	BIT Group France	Montpellier Herault, FR

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012319642. Last updated year: 2026. Please use registration number 3012319642 when referencing this establishment in official correspondence.