Identity
- Trade Name
- SIBERIAN FIT® EUDAMED
- Device Name
- SIBERIAN FIT® EUDAMED
- Model / Reference
- 17615 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898961835440 EUDAMED
- Basic UDI-DI
- 789896183SIBERIANFITBM EUDAMEDB-07898961835440 EUDAMED
- Direct Marketing DI
- 07898961835440 EUDAMED
- EMDN Code
- Z120499 GENERAL MEDICINE INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Siberian Fit® by Vydence Medical – Indústria e Comércio Ltda — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 789896183SIBERIANFITBM | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 789896183SIBERIANFITBM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Vydence Medical – Indústria e Comércio Ltda
- EUDAMED SRN
- BR-MF-000041042
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 399468e0-82a3-450d-af7c-d27e773be4c4 61 fields · synced Sep 17, 2026
- EUDAMED 5eaa957c-d52c-461d-b76b-5b037c8fd441 61 fields · synced Jun 20, 2026