MEDION GRIFOLS DIAGNOSTICS AG

FDA Device Registration & Listing · DUEDINGEN Fribourg, CH · Registration 3002806769

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002806769
FEI Number
3002806769
Entity Name
MEDION GRIFOLS DIAGNOSTICS AG
City/State/Country
DUEDINGEN Fribourg, CH
Establishment Address
BONNSTRASSE 9, DUEDINGEN Fribourg CH-3186, CH
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MEDION GRIFOLS DIAGNOSTICS AG (Owner Number: 9090520)
Owner / Operator Contact Address
Avda. de la Generalitat, 152, Sant Cugat del Valles, ES-B 08174, ES
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
BK180280
PMA Number
N/A

All Registered Proprietary Names

Reagent Red Blood Cells Coombs Control Cells DG Gel Essential Control

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KSM System, Test, Combs, Automated Hematology Class 2 864.9300 2009-03-17
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2019-04-11

Official Correspondent

No official correspondent registered.

US Agent Details

Alisha McReynolds Email: alisha.mcreynolds@grifols.com Phone: (510) 9235046

Related Public Records

Same Entity

MEDION GRIFOLS DIAGNOSTICS AG
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002806769. Last updated year: 2026. Please use registration number 3002806769 when referencing this establishment in official correspondence.
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