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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
- 06935740739412 EUDAMED06935740733465 EUDAMED06935740733472 EUDAMED06935740733458 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
Apolipoprotein A1 (Apo A1) Assay Kit (Immunoturbidimetric Assay) by URIT Medical Electronic Co., Ltd. — Class B — IVDR — listed in EUDAMED
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 (4)
- EUDAMED 0a069393-dc58-44b7-92ab-b4531e5c1a56 61 fields · synced Oct 6, 2026
- EUDAMED 22bee62a-9c37-4d60-bc04-1c552199a218 61 fields · synced May 18, 2026
- EUDAMED 3548748b-b078-43ca-b4c0-c27039a34c49 61 fields · synced May 18, 2026
- EUDAMED 67f06540-e4fd-4d66-a50b-d613b67d3205 61 fields · synced May 18, 2026