Identity
- Device Name
- Fascia per ernia EUDAMED
- Model / Reference
- 538 EUDAMED538, mis.M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055965375740 EUDAMED
- Basic UDI-DI
- 805596537538JE EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE 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
Fascia per ernia 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 | 805596537538JE | 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 b0a6372d-9ff2-4375-a999-5c2a521c3907 61 fields · synced Jul 15, 2026
- EUDAMED b0a6372d-9ff2-4375-a999-5c2a521c3907-1 61 fields · synced Jun 10, 2026