Identity
- Trade Name
- HbA1c Control Normal EUDAMED
- Device Name
- HbA1c Control Normal EUDAMED
- Model / Reference
- 981695 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153816956 EUDAMED
- Basic UDI-DI
- B-16438153816956 EUDAMED6438153BU00026BK EUDAMED
- Direct Marketing DI
- 16438153816956 EUDAMED
- EMDN Code
- W0103010199 REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER EUDAMEDW01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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 Control Normal by Thermo Fisher Scientific Oy — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-16438153816956 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-16438153816956 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (2)
- EUDAMED f0bcfeeb-e587-415e-8476-4150b829358e 61 fields · synced Jul 9, 2026
- EUDAMED 30159a82-2c0a-48c5-b1d9-5aed6803d5df 61 fields · synced May 17, 2026