Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003749380

FEI Number

3003749380

Entity Name

DIAGAM S.A.

City/State/Country

Ghislenghien Hainaut, BE

Establishment Address

rue du parc industriel 40, Ghislenghien Hainaut 7822, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Diagam S.A. (Owner Number: 10057026)

Owner / Operator Contact Address

Rue du Parc Industriel 40, Ghislenghien, BE-WHT 7822, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Alpha2-Macroglobulin Serum CONT KIT Alpha2-Macroglobulin Calibrator Kit Alpha2-Macroglobulin (08240396190) Alpha2-Macroglobulin Serum Control Kit Alpha2-Macroglobulin CAL KIT Alpha2-Macroglobulin (09029524190)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DEB	Alpha-2-Macroglobulin, Antigen, Antiserum, Control	Immunology	Class 2	866.5620	2018-02-13

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Diagam S.A.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003749380. Last updated year: 2026. Please use registration number 3003749380 when referencing this establishment in official correspondence.