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VagiVital AL
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref FPCSABVV001
Identity
- Trade Name
- VagiVital AL EUDAMED
- Device Name
- AL-SENSE EUDAMED
- Model / Reference
- FPCSABVV001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290006558008 EUDAMED
- Basic UDI-DI
- B-07290006558008 EUDAMED
- EMDN Code
- W02010199 CHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
VagiVital AL by Peptonic Medical Israel Ltd — 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-07290006558008 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Peptonic Medical Israel Ltd
- EUDAMED SRN
- IL-MF-000029152
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 3eafff81-05b1-48cc-aaac-1861ffc6a851 61 fields · synced Jul 10, 2026