Identity
- Trade Name
- OrtoFlex EUDAMED
- Model / Reference
- OrtoFlex EUDAMED02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05901085023005 EUDAMED
- Basic UDI-DI
- 5901085023ORTOFLEX74 EUDAMED
- Direct Marketing DI
- 05901085023005 EUDAMED
- EMDN Code
- Z120603 PASSIVE REHABILITATIVE GYMNASTICS EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa 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
OrtoFlex by Good Medica Spółka z ograniczoną odpowiedzialnością — Class IIa — 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 | 5901085023ORTOFLEX74 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Good Medica Spółka z ograniczoną odpowiedzialnością
- EUDAMED SRN
- PL-MF-000027329
Sources (1)
- EUDAMED 78f1bf75-c6cb-456a-b871-a2258c4378db 61 fields · synced Oct 6, 2026