Identity
- Trade Name
- GELSCAN EUDAMED
- Device Name
- GELSCAN EUDAMED
- Model / Reference
- 1206 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03607360012062 EUDAMED
- Basic UDI-DI
- 3607361206BUBH EUDAMED
- EMDN Code
- W020105010203 DENSITOMETERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Gelscan by Sebia — Class A — 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 | 3607361206BUBH | Class A | Active |
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Manufacturer
- Manufacturer
- sebia
- EUDAMED SRN
- FR-MF-000003520
Sources (1)
- EUDAMED fe9dd0cb-8cbd-40dc-b947-5befdf443fb9 61 fields · synced Jul 10, 2026