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Urinary Tract Infections Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref U031-04H
Identity
- Trade Name
- Urinary Tract Infections Test EUDAMED
- Device Name
- Urinary Tract Infections Test EUDAMED
- Model / Reference
- U031-04H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983105729 EUDAMED07350123504576 EUDAMED
- Basic UDI-DI
- B-06936983105729 EUDAMEDB-07350123504576 EUDAMED
- EMDN Code
- W0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Croatia EUDAMEDIreland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
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
Urinary Tract Infections Test by Hangzhou Alltest Biotech.Co., Ltd. — Class IVD devices for self-testing — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06936983105729 | Class IVD devices for self-testing | Unknown |
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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 (2)
- EUDAMED b168da73-0840-459a-b7b8-e3003636d689 61 fields · synced Jun 20, 2026
- EUDAMED 67e2ce1b-a196-4eaa-93b4-41e17598e883 61 fields · synced Jun 20, 2026