Identity
- Trade Name
- ProfiTEX orteză claviculară II EUDAMED
- Device Name
- Orteză cervicotoracică EUDAMED
- Model / Reference
- 4X.H-21-II EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944784004302 EUDAMED
- Basic UDI-DI
- 5944784ORTPTCVCERVICOTO5N EUDAMED
- Direct Marketing DI
- 05944784004302 EUDAMED
- EMDN Code
- Y060315 CERVICOTHORACIC SPINE ORTHOSES 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 orteză claviculară II 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 | 5944784ORTPTCVCERVICOTO5N | 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 9f0cf522-837f-42f2-bea6-0a75fa47ed53 61 fields · synced Oct 6, 2026