Identity
- Trade Name
- HbA1c EUDAMED
- Device Name
- HbA1c EUDAMED
- Model / Reference
- 981947 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153002397 EUDAMED
- Basic UDI-DI
- 6438153BU00022BB EUDAMEDB-16438153002397 EUDAMED
- Direct Marketing DI
- 16438153002397 EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMEDW01030199 HAEMATOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
HbA1c by Thermo Fisher Scientific Oy — Class C — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 6438153BU00022BB | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 6438153BU00022BB | Class C | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (2)
- EUDAMED 690817cf-3953-48b4-ab08-fc54a88d114f 61 fields · synced Oct 6, 2026
- EUDAMED a82c7e93-ec12-45ae-bcb0-07e8d7b615fa 61 fields · synced May 17, 2026