Identity
- Trade Name
- ProfiTEX PodoCare HEEL SPUR 45 EUDAMED
- Device Name
- Orteză corectoare de statică a piciorului EUDAMED
- Model / Reference
- 4STO.HEEL SPUR-45 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944784003190 EUDAMED
- Basic UDI-DI
- 5944784ORTMEMBRUINFOCSPKV EUDAMED
- Direct Marketing DI
- 05944784003190 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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 PodoCare HEEL SPUR 45 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 | 5944784ORTMEMBRUINFOCSPKV | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OrtoProfil Prod Romania SRL
- EUDAMED SRN
- RO-MF-000000526
Sources (1)
- EUDAMED 3a863d7a-330f-45cc-b230-8b9067e1f4b0 61 fields · synced Aug 1, 2026