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Urine Microalbumin (MAU) Test
EUDAMEDClass IVD General (EU MDR)
Ref RH-UALBModel strip, cassette, midstream
Identity
- Device Name
- Urine Microalbumin (MAU) Test EUDAMED
- Model / Reference
- strip, cassette, midstream EUDAMEDRH-UALB EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69384449UALBZN EUDAMED
- Basic UDI-DI
- B-69384449UALBZN EUDAMED
- EMDN Code
- W0102160199 SPECIFIC PROTEINS RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Urine Microalbumin (MAU) Test by Equinox Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-69384449UALBZN | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Equinox Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000018901
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 4e52658e-ba5e-4749-93b5-1887b194fd24 61 fields · synced Jun 19, 2026