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Urinalysis Reagent Strips (Urine)
EUDAMEDClass IVD General (EU MDR)
Ref U031-02-003
Identity
- Trade Name
- Urinalysis Reagent Strips (Urine) EUDAMED
- Device Name
- Urinalysis Reagent Strips (Urine) EUDAMED
- Model / Reference
- U031-02-003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942598223772 EUDAMED
- Basic UDI-DI
- B-06942598223772 EUDAMED
- EMDN Code
- W0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) EUDAMED
Classification
- Device Class
- Class IVD General 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
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Urinalysis Reagent Strips (Urine) by Hangzhou Alltest Biotech.Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06942598223772 | Class IVD General | 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 (1)
- EUDAMED 57a35865-d605-42b9-852b-ce4eee80f022 61 fields · synced Jun 17, 2026