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Orteza stawu skokowego MEK 9009 S
EUDAMEDClass I (EU MDR)
Ref 9009-sModel MEK 9009
Identity
- Trade Name
- Orteza stawu skokowego MEK 9009 S EUDAMED
- Device Name
- Stabilizator stawu skokowego (ze stalkami bocznymi i dodatkowymi taśmami) EUDAMED
- Model / Reference
- MEK 9009 EUDAMED9009-s EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904647710726 EUDAMED
- Basic UDI-DI
- 59046477190097N 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
Category: Ankle/foot orthosis
Orteza stawu skokowego MEK 9009 S by MEK-ORTO Sp. z o.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 | 59046477190097N | Class I | Active |
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Manufacturer
- Manufacturer
- MEK-ORTO Sp. z o.o.
- EUDAMED SRN
- PL-MF-000019251
Sources (1)
- EUDAMED 5186c70f-b520-49c0-8e81-9ce2fec1348d 61 fields · synced Sep 17, 2026