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Clearblue Ultratidigt AVANCERAT Graviditetstest
EUDAMEDClass B (EU MDR)
Ref 08006530245913Model CB16
Identity
- Trade Name
- Clearblue Ultratidigt AVANCERAT Graviditetstest EUDAMED
- Device Name
- Clearblue Ultra Early Advanced Pregnancy Test EUDAMED
- Model / Reference
- CB16 EUDAMED08006530245913 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08006530245913 EUDAMED
- Basic UDI-DI
- 4084500CB16QX EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Sweden 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 Ultratidigt AVANCERAT Graviditetstest 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 | 4084500CB16QX | 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 a2f158ab-49f6-43f5-9a7c-77c3dd841998 61 fields · synced Jul 8, 2026