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Tests de détection des signes d'infections des voies urinaires (Urine)
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref U031-04H
Identity
- Trade Name
- Tests de détection des signes d'infections des voies urinaires (Urine) EUDAMED
- Device Name
- Tests de détection des signes d'infections des voies urinaires (Urine) EUDAMED
- Model / Reference
- U031-04H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942598217283 EUDAMED
- Basic UDI-DI
- B-06942598217283 EUDAMED
- EMDN Code
- W0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Tests de détection des signes d'infections des voies urinaires (Urine) by Hangzhou Alltest Biotech.Co., Ltd. — Class IVD devices for self-testing — IVDD…
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-06942598217283 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 80f7e6b8-e87c-4e1e-873e-066feca4adab 61 fields · synced Jun 18, 2026