Identity
- Device Name
- Gomitiera EUDAMED
- Model / Reference
- 613 EUDAMED613, mis.XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08051566282678 EUDAMED
- Basic UDI-DI
- 805156628613D4 EUDAMED
- EMDN Code
- Y060615 ELBOW ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Gomitiera by G.l.o. Srl — 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 | 805156628613D4 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- G.l.o. Srl
- EUDAMED SRN
- IT-MF-000018554
Sources (2)
- EUDAMED 87dac59d-9e7d-44e3-bcb0-1f4b51ba1791 61 fields · synced Jun 19, 2026
- EUDAMED 87dac59d-9e7d-44e3-bcb0-1f4b51ba1791-1 61 fields · synced Jun 10, 2026