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Urine Microalbumin Test Strip
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref Model mALB-1：125000007、Model mALB-2：125000009、Model mALB-3：125000008Model mALB-1 、mALB-2、mALB-3
Identity
- Device Name
- Urine Microalbumin Test Strip EUDAMED
- Model / Reference
- mALB-1 、mALB-2、mALB-3 EUDAMEDModel mALB-1：125000007、Model mALB-2：125000009、Model mALB-3：125000008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06914329008811 EUDAMED
- Basic UDI-DI
- B-06914329008811 EUDAMED
- EMDN Code
- W0102160101 ALBUMIN INCL. UALBUMIN RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Urine Microalbumin Test Strip by Beijing Yicheng Bioelectronics Technology Co., Ltd. — Class IVD devices for self-testing — 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-06914329008811 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Beijing Yicheng Bioelectronics Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000033130
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 9c0435f0-aa59-4684-b568-e3a1d100fe41 61 fields · synced Jul 14, 2026