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Apolipoprotein A1 (Apo A1) Assay Kit (Immunoturbidimetric Assay)
EUDAMEDClass B (EU MDR)
Ref /
Identity
- Device Name
- Apolipoprotein A1 (Apo A1) Assay Kit (Immunoturbidimetric Assay) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740733489 EUDAMED
- Basic UDI-DI
- 69357407ICAS000037B5 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
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 (Apo A1) Assay Kit (Immunoturbidimetric Assay) by URIT Medical Electronic Co., Ltd. — Class B — IVDR — listed in EUDAMED
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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 | 69357407ICAS000037B5 | Class B | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 81a73e96-e432-441d-b0d3-a37d9bc02092 61 fields · synced Jun 19, 2026