Identity
- Trade Name
- Apo A1/Apo B Calibrator EUDAMED
- Device Name
- Apo A1/Apo B Calibrator EUDAMED
- Model / Reference
- 981921 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153819216 EUDAMED
- Basic UDI-DI
- 6438153BU00172BX EUDAMED
- Direct Marketing DI
- 16438153819216 EUDAMED
- EMDN Code
- W0102152203 SPECIFIC PROTEIN STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Apo A1/Apo B Calibrator by Thermo Fisher Scientific Oy — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6438153BU00172BX | Class B | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (1)
- EUDAMED eeac38a1-1a05-4b2e-b838-c7b22e1e8df6 61 fields · synced Jul 14, 2026