Identity
- Device Name
- Apolipoprotein AⅠ (ApoAⅠ) EUDAMED
- Model / Reference
- ECH0501157 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ECH05011576R EUDAMED
- Basic UDI-DI
- B-ECH05011576R EUDAMED
- EMDN Code
- W0102010401 APOLIPOPROTEIN A I EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Category: Apolipoprotein A-I (Apo A1) IVD, reagent
Apolipoprotein AⅠ (ApoAⅠ) by Maccura Biotechnology Co., Ltd. — Class IVD General — IVDD — 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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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-ECH05011576R | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED cf8f05a8-c950-4406-b8c4-e3c7817524a0 61 fields · synced Jun 19, 2026