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Clearblue Teste de gravidez com Indicador de Semanas
EUDAMEDClass B (EU MDR)
Ref 05013965723407Model CB9
Identity
- Trade Name
- Clearblue Teste de gravidez com Indicador de Semanas EUDAMED
- Device Name
- Clearblue Pregnancy Test with Weeks Indicator EUDAMED
- Model / Reference
- CB9 EUDAMED05013965723407 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05013965723407 EUDAMED
- Basic UDI-DI
- 4084500CB985 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Clearblue Teste de gravidez com Indicador de Semanas by Spd Swiss Precision Diagnostics Gmbh — Class B — 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 | 4084500CB985 | Class B | Active |
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Manufacturer
- Manufacturer
- SPD Swiss Precision Diagnostics GmbH
- EUDAMED SRN
- CH-MF-000025175
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 9851dc15-5ab2-4032-b083-e065fc78809f 61 fields · synced Jul 8, 2026