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Urine Microalbumin Kit (Latex Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref /
Identity
- Device Name
- Urine Microalbumin Kit (Latex Immunoturbidimetric Method) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-12H7V EUDAMED
- Basic UDI-DI
- B-12H7V EUDAMED
- EMDN Code
- W0102010309 ALBUMIN (IC) INCL. UALBUMIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Urine Microalbumin Kit (Latex Immunoturbidimetric Method) by Shanghai Kehua Bio-engineering Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-12H7V | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shanghai Kehua Bio-engineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000026756
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 96e68232-be11-42f3-b37e-fff6c2598284 61 fields · synced Jul 16, 2026