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Semi-quantitative Albumin Urine Test
EUDAMEDClass IVD General (EU MDR)
Ref SQ50-110Ref SQ50-112
Identity
- Device Name
- Semi-quantitative Albumin Urine Test EUDAMED
- Model / Reference
- SQ50-110 EUDAMEDSQ50-112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941571850103 EUDAMED06941571850110 EUDAMED
- Basic UDI-DI
- B-06941571850103 EUDAMEDB-06941571850110 EUDAMED
- EMDN Code
- W0102160101 ALBUMIN INCL. UALBUMIN RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Semi-quantitative Albumin Urine Test by Ameritech Diagnostic Reagent (Jiaxing) 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-06941571850103 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020607
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED cb15120b-d27e-4675-baf6-7768403baa3c 61 fields · synced Oct 5, 2026
- EUDAMED 304c4774-679e-4bd8-a7a3-89f184f4b362 61 fields · synced May 18, 2026