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Ultra Early Advanced Pregnancy Test
EUDAMEDClass B (EU MDR)
Ref 08006530242813Model CB16
Identity
- Trade Name
- Ultra Early Advanced Pregnancy Test EUDAMED
- Device Name
- Ultra Early Advanced Pregnancy Test, Early Detection Advanced Pregnancy Test, Dual Hormone Pregnancy Test EUDAMED
- Model / Reference
- CB16 EUDAMED08006530242813 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08006530242813 EUDAMED
- Basic UDI-DI
- 4084500CB16QX EUDAMED
- Unit of Use DI
- 00633472000584 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Ireland 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
Ultra Early Advanced Pregnancy Test 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 45280245-fe4d-4126-ac55-8a7a23cb74c5 61 fields · synced Aug 1, 2026