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Clearblue Schwangerschaftstest Flip & Click
EUDAMEDClass B (EU MDR)
Ref 08700216517829Model CB11/CB11A
Identity
- Trade Name
- Clearblue Schwangerschaftstest Flip & Click EUDAMED
- Device Name
- Rapid Detection Pregnancy Test, Easy Pregnancy Test, Pregnancy Test Flip & Click EUDAMED
- Model / Reference
- CB11/CB11A EUDAMED08700216517829 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08700216517829 EUDAMED
- Basic UDI-DI
- 4084500CB11/CB11AUR EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class B 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
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Clearblue Schwangerschaftstest Flip & Click 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 | 4084500CB11/CB11AUR | 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 c112f7c3-14bb-40d2-8a45-565ef5d7b809 61 fields · synced Aug 1, 2026