Identity
- Trade Name
- ORTEZA EUDAMED
- Device Name
- Orteza EUDAMED
- Model / Reference
- Orteza EUDAMEDP-5907739317506 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907739317506 EUDAMED
- Basic UDI-DI
- 590773931ORTEZAUT EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Orteza by 4fizjo Group Sp. Z O. O. — 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 | 590773931ORTEZAUT | Class I | Active |
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Manufacturer
- Manufacturer
- 4fizjo Group Sp. Z O. O.
- EUDAMED SRN
- PL-MF-000031702
Sources (1)
- EUDAMED 04cfaa24-a00b-4fe3-adc4-205dc3b58900 61 fields · synced Jun 18, 2026