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Apolipoprotein A1 Kit (Turbidimetry Method)
EUDAMEDClass B (EU MDR)
Ref 105-004602-00Model 105-000837-00、105-000876-00、105-004602-00
Identity
- Trade Name
- Apolipoprotein A1 Kit (Turbidimetry Method) EUDAMED
- Device Name
- Apolipoprotein A1 Kit (Turbidimetry Method) EUDAMED
- Model / Reference
- 105-000837-00、105-000876-00、105-004602-00 EUDAMED105-004602-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944904050805 EUDAMED
- Basic UDI-DI
- 694490400041ApoA1******EC EUDAMED
- EMDN Code
- W0102010401 APOLIPOPROTEIN A I EUDAMED
Classification
- Device Class
- Class B 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
New Device
No
EUDAMED
Category: Apolipoprotein A-I (Apo A1) IVD, reagent
Apolipoprotein A1 Kit (Turbidimetry Method) by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Class B — IVDR — listed in EUDAMED
Similar devices
Also classified as Apolipoprotein A-I (Apo A1) IVD, reagent.
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- Apolipoprotein AⅠ (ApoAⅠ) — Maccura Biotechnology Co., Ltd. · IVD General
- 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 | 694490400041ApoA1******EC | Class B | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 35890e1c-cad5-40cb-9503-5a2953d8ecdf 61 fields · synced Jun 18, 2026