Identity
- Trade Name
- Apolipoprotein A1 EUDAMED
- Device Name
- Apolipoprotein A1 EUDAMED
- Model / Reference
- 981929 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153819292 EUDAMED
- Basic UDI-DI
- 6438153BU00173BZ EUDAMED
- Direct Marketing DI
- 16438153819292 EUDAMED
- EMDN Code
- W0102010401 APOLIPOPROTEIN A I EUDAMED
Classification
- Device Class
- Class B 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
Category: Apolipoprotein A-I (Apo A1) IVD, reagent
Apolipoprotein A1 by Thermo Fisher Scientific Oy — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Apolipoprotein A-I (Apo A1) IVD, reagent.
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- Apolipoprotein A1 Reagent Kit — HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD. · IVD General
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 | 6438153BU00173BZ | Class B | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (1)
- EUDAMED e4244af5-a50d-4886-9387-164555989bd2 61 fields · synced Jun 20, 2026