← Back to catalogue
Urine Analysis Test Strip(Urine)
EUDAMEDClass IVD General (EU MDR)
Ref URS-1111
Identity
- Trade Name
- Urine Analysis Test Strip(Urine) EUDAMED
- Device Name
- Urine Analysis Test Strip(Urine) EUDAMED
- Model / Reference
- URS-1111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-697424646URS000T7CM EUDAMED
- Basic UDI-DI
- B-697424646URS000T7CM EUDAMED
- EMDN Code
- W0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) 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
Urine Analysis Test Strip(Urine) by Safecare Biotech (Hangzhou) 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-697424646URS000T7CM | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Safecare Biotech (hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000019109
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED f379133f-5d78-443a-a1f8-635a7ad1faa3 61 fields · synced Jun 19, 2026