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Urinary Tract Infection Self Test
EUDAMEDFDA 510(k)Class IVD devices for self-testing (EU MDR)
Ref U031-04H
Identity
- Trade Name
- Urinary Tract Infection Self Test EUDAMED
- Device Name
- Urinary Tract Infection Self Test EUDAMED
- Model / Reference
- U031-04H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983164023 EUDAMED
- Basic UDI-DI
- B-06936983164023 EUDAMED
- EMDN Code
- W0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Urinary Tract Infection Self Test by Hangzhou Alltest Biotech.Co., Ltd. — Class IVD devices for self-testing — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252607 | Class IVD devices for self-testing | Active |
| EUDAMED | European Union | CE/IVDD | B-06936983164023 | 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 (2)
- EUDAMED 75fef652-3f68-41bc-9a5d-6f2106da3ff0 61 fields · synced Oct 6, 2026
- FDA 510(k) K252607 1 fields · synced May 18, 2026