Identity
- Trade Name
- ProfiTEX Ghete 30 EUDAMED
- Device Name
- Ghete ortopedice EUDAMED
- Model / Reference
- 4I.GO 031-30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944784004975 EUDAMED
- Basic UDI-DI
- 5944784GHEORT6L EUDAMED
- Direct Marketing DI
- 05944784004975 EUDAMED
- EMDN Code
- Y063303 READY-MADE ORTHOTIC SHOES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
ProfiTEX Ghete 30 by OrtoProfil Prod Romania 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 | 5944784GHEORT6L | Class I | Active |
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Manufacturer
- Manufacturer
- OrtoProfil Prod Romania SRL
- EUDAMED SRN
- RO-MF-000000526
Sources (1)
- EUDAMED 8a67674f-81ec-4f96-a8c4-b19682387077 61 fields · synced Aug 3, 2026