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Bioaxon Rapid Test Dipstick ( Urine ) Pregnancy (hCG) Rapid Test Dipstick ( Uri…
EUDAMEDClass A (EU MDR)
Ref BIO - 101
by Bioaxan
Identity
- Device Name
- Bioaxon Rapid Test Dipstick ( Urine ) Pregnancy (hCG) Rapid Test Dipstick ( Urine ) EUDAMED
- Model / Reference
- BIO - 101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230166405870 EUDAMED
- Basic UDI-DI
- 6223016640101RG EUDAMED
- EMDN Code
- W0102160303 HPL - RT & POC EUDAMED
Classification
- Device Class
- Class A EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Bioaxon Rapid Test Dipstick ( Urine ) Pregnancy (hCG) Rapid Test Dipstick ( Uri… by Bioaxan — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6223016640101RG | Class A | Active |
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Manufacturer
- Manufacturer
- Bioaxan
- EUDAMED SRN
- EG-MF-000040545
- Authorised Representative
- EUCEREP B.V. NL-AR-000001966
Sources (1)
- EUDAMED fde7baa5-31cf-455d-9683-d500a74b371e 61 fields · synced Oct 6, 2026