Identity
- Trade Name
- ProfiTEX Ham Pavlik I EUDAMED
- Device Name
- Orteză pentru luxația de șold congenitală la copii EUDAMED
- Model / Reference
- 4X.PAVLIK-I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944784000038 EUDAMED
- Basic UDI-DI
- 5944784ORTMEMBRUINFLSCCKE EUDAMED
- Direct Marketing DI
- 05944784000038 EUDAMED
- EMDN Code
- Y061215 HIP ORTHOSES (INCLUDING ABDUCTION 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 Ham Pavlik I 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 | 5944784ORTMEMBRUINFLSCCKE | Class I | Active |
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Manufacturer
- Manufacturer
- OrtoProfil Prod Romania SRL
- EUDAMED SRN
- RO-MF-000000526
Sources (1)
- EUDAMED 0a1e0848-6894-4445-bed7-0a46695f7263 61 fields · synced Oct 6, 2026