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Ortéza kolena KO-43, bez výstuže
EUDAMEDClass I (EU MDR)
Ref 8585063863882Model Knee orthose
Identity
- Trade Name
- Ortéza kolena KO-43, bez výstuže EUDAMED
- Model / Reference
- Knee orthose EUDAMED8585063863882 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585063863882 EUDAMED
- Basic UDI-DI
- 858506KO43XLA5 EUDAMED
- Direct Marketing DI
- 08585063863882 EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovakia 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
Ortéza kolena KO-43, bez výstuže by PROTETIKA, a.s. — 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 | 858506KO43XLA5 | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (1)
- EUDAMED 2fff036f-2d2e-429e-bcb8-337e7de73805 61 fields · synced Jul 9, 2026