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Test ciążowy płytkowy Sanovia
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 0020WModel Cassette pregnancy test, Sensitivity: 10 mIU/ml
Identity
- Trade Name
- Test ciążowy płytkowy Sanovia EUDAMED
- Device Name
- Test ciążowy płytkowy Sanovia EUDAMED
- Model / Reference
- Cassette pregnancy test, Sensitivity: 10 mIU/ml EUDAMED0020W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907581250709 EUDAMED
- Basic UDI-DI
- B-05907581250709 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Poland 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
Test ciążowy płytkowy Sanovia by Diagnosis S.a. — Class IVD devices for self-testing — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05907581250709 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Diagnosis S.a.
- EUDAMED SRN
- PL-MF-000014187
Sources (1)
- EUDAMED 00dddcff-9d36-48db-8701-a92665df37bf 61 fields · synced Jun 20, 2026