Identity
- Device Name
- KAFO COMPACT Orteza EUDAMED
- Model / Reference
- DRQI7A1LAXUXP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05901780451363 EUDAMED
- Basic UDI-DI
- 59017804DRQI7AMK EUDAMED
- Direct Marketing DI
- 05901780451363 EUDAMED
- EMDN Code
- Y06121201 PASSIVE KNEE-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
KAFO COMPACT Orteza by mdh 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 | 59017804DRQI7AMK | Class I | Active |
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Manufacturer
- Manufacturer
- mdh sp. z o. o.
- EUDAMED SRN
- PL-MF-000011406
Sources (1)
- EUDAMED 147f91f8-55f9-4178-8e3c-ad15fd422557 61 fields · synced Jun 18, 2026