Identity
- Trade Name
- ProfiTEX PodoCare ORTOMED PP44 EUDAMED
- Device Name
- Orteză corectoare de statică a piciorului EUDAMED
- Model / Reference
- 4T.S-200-PP-44 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944784003145 EUDAMED
- Basic UDI-DI
- 5944784ORTMEMBRUINFOCSPKV EUDAMED
- Direct Marketing DI
- 05944784003145 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 ORTOMED PP44 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 bf465edd-25fb-476d-ae1a-df3bb84daf8a 61 fields · synced Jul 31, 2026