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α1-Microglobulin (α1-MG) testing kit (Latex Immunoturbidimetric Assay)
EUDAMEDClass B (EU MDR)
Ref /
Identity
- Device Name
- α1-Microglobulin (α1-MG) testing kit (Latex Immunoturbidimetric Assay) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740733380 EUDAMED06935740733366 EUDAMED06935740739368 EUDAMED06935740733359 EUDAMED
- Basic UDI-DI
- 69357407ICAS000033AV EUDAMED
- EMDN Code
- W0102019004 A1-MICROGLOBULIN 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
α1-Microglobulin (α1-MG) testing kit (Latex 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 | 69357407ICAS000033AV | 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 af1fdb07-0a4c-47ad-bec6-51333de1372c 61 fields · synced Oct 6, 2026
- EUDAMED c16394b5-a3f3-46ce-8f84-ae1985df492d 61 fields · synced May 18, 2026
- EUDAMED c5925bbb-5735-4172-a5c8-0c9b1124485e 61 fields · synced May 18, 2026
- EUDAMED 33432133-09e8-4bb8-a073-fc3c76d3bd7a 61 fields · synced May 19, 2026