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Ortéza kolena so silikónovou pelotou, KO-42
EUDAMEDClass I (EU MDR)
Ref 8585003411753Model Knee orthose
Identity
- Trade Name
- Ortéza kolena so silikónovou pelotou, KO-42 EUDAMED
- Model / Reference
- Knee orthose EUDAMED8585003411753 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003411753 EUDAMED
- Basic UDI-DI
- 858500J86366KO42XSAE EUDAMED
- Direct Marketing DI
- 08585003411753 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 so silikónovou pelotou, KO-42 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 | 858500J86366KO42XSAE | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (1)
- EUDAMED 26211b0b-464f-406c-b485-da76ec2a9d5a 61 fields · synced Jul 10, 2026