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Urinary Tract Infection (UTI) &DR Panel (Fluorescence PCR method)
EUDAMEDClass IVD General (EU MDR)
Ref PR2024-UT01Model 24 samples/kit
Identity
- Device Name
- Urinary Tract Infection (UTI) &DR Panel (Fluorescence PCR method) EUDAMED
- Model / Reference
- 24 samples/kit EUDAMEDPR2024-UT01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974541565509 EUDAMED
- Basic UDI-DI
- B-06974541565509 EUDAMED
- EMDN Code
- W01010999 MULTIPLE PARAMETERS URINE TESTING - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Urinary Tract Infection (UTI) &DR Panel (Fluorescence PCR method) by Bioteke Corporation (Wuxi) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06974541565509 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- BioTeke Corporation（Wuxi）Co., Ltd
- EUDAMED SRN
- CN-MF-000007517
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 0f23873d-3aae-4047-8836-bd1d4ec1b990 61 fields · synced Oct 7, 2026