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Orteza Stawu Skokowego "malleomax"
EUDAMEDClass I (EU MDR)
Ref O-1160/MModel O-1160
Identity
- Trade Name
- ORTEZA STAWU SKOKOWEGO "MALLEOMAX" EUDAMED
- Device Name
- Orteza stawu skokowego "MALLEOMAX" EUDAMED
- Model / Reference
- O-1160 EUDAMEDO-1160/M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903940710952 EUDAMED
- Basic UDI-DI
- 59039407O1160DK EUDAMED
- Direct Marketing DI
- 05903940710952 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT 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 Stawu Skokowego "malleomax" by REHA FUND 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 | 59039407O1160DK | Class I | Active |
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Manufacturer
- Manufacturer
- REHA FUND Sp. z o.o.
- EUDAMED SRN
- PL-MF-000047481
Sources (1)
- EUDAMED a48785ba-30c8-4b1b-8842-3834b2c5e9c5 61 fields · synced Oct 9, 2026