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Preventis SmarTest® Vitamin D Home
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref PST80100EP08
Identity
- Trade Name
- Preventis SmarTest® Vitamin D Home EUDAMED
- Device Name
- Preventis SmarTest® Vitamin D Home EUDAMED
- Model / Reference
- PST80100EP08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050598009103 EUDAMED
- Basic UDI-DI
- B-04050598009103 EUDAMED
- EMDN Code
- W0102060309 25-HYDROXYVITAMIN D EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Preventis SmarTest® Vitamin D Home by Immundiagnostik AG — 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-04050598009103 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Immundiagnostik AG
- EUDAMED SRN
- DE-MF-000020905
Sources (1)
- EUDAMED 0e764a51-4881-4413-90cc-3214c49fd15b 61 fields · synced Jul 19, 2026