Identity
- Trade Name
- ProfiTEX Guler Schanz II EUDAMED
- Device Name
- Orteză cervicală EUDAMED
- Model / Reference
- 4X.GU-110-II EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944784004166 EUDAMED
- Basic UDI-DI
- 5944784ORTPTCVORTCERVICGK EUDAMED
- Direct Marketing DI
- 05944784004166 EUDAMED
- EMDN Code
- Y060312 CERVICAL 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 Guler Schanz 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 | 5944784ORTPTCVORTCERVICGK | Class I | Active |
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Manufacturer
- Manufacturer
- OrtoProfil Prod Romania SRL
- EUDAMED SRN
- RO-MF-000000526
Sources (1)
- EUDAMED c8c3213e-4d7d-447f-8fa5-85f149fb43b4 61 fields · synced Jun 19, 2026