Identity
- Device Name
- Polpaccera EUDAMED
- Model / Reference
- 612 EUDAMED612, mis.M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08051070435096 EUDAMED
- Basic UDI-DI
- 8051070436127R EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER 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
Polpaccera 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 | 8051070436127R | Class I | Active |
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Manufacturer
- Manufacturer
- G.l.o. Srl
- EUDAMED SRN
- IT-MF-000018554
Sources (2)
- EUDAMED d09e06c7-ba24-4a5c-8a7e-e0fc68a4928e 61 fields · synced Jul 30, 2026
- EUDAMED d09e06c7-ba24-4a5c-8a7e-e0fc68a4928e-1 61 fields · synced Jun 10, 2026