Identity
- Trade Name
- LiNA Versascope Sheath EUDAMED
- Device Name
- LiNA Versascope Sheath EUDAMED
- Model / Reference
- GMS 805 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708265013531 EUDAMED
- Basic UDI-DI
- 57082651023-1ZH EUDAMED
- Direct Marketing DI
- 05708265013531 EUDAMED
- EMDN Code
- Z12020799 GENITOURINARY ENDOSCOPY INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
Yes
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
LiNA Versascope Sheath by Lina Medical ApS — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 57082651023-1ZH | Class I | Active |
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Manufacturer
- Manufacturer
- LiNA Medical ApS
- EUDAMED SRN
- DK-MF-000003706
Sources (1)
- EUDAMED 5044d949-45df-41df-9c95-687bf0848782 61 fields · synced Jun 18, 2026