← Back to catalogue
Neoprenová bandáž kolena KO-6
EUDAMEDClass I (EU MDR)
Ref J 58378Model Knee orthose
Identity
- Trade Name
- Neoprenová bandáž kolena KO-6 EUDAMEDNeoprénová bandáž kolena KO-6 EUDAMED
- Model / Reference
- Knee orthose EUDAMEDJ 58378 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003412415 EUDAMED08585003412385 EUDAMED08585003412378 EUDAMED08585003412392 EUDAMED
- Basic UDI-DI
- 858500J58378KO6XXLGR EUDAMED858500J58378KO6MN4 EUDAMED858500J58378KO6SNG EUDAMED858500J58378KO6LN2 EUDAMED
- Direct Marketing DI
- 08585003412415 EUDAMED08585003412385 EUDAMED08585003412378 EUDAMED08585003412392 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
Neoprenová bandáž kolena KO-6 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 | 858500J58378KO6XXLGR | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (4)
- EUDAMED 6b7405d6-3e5d-42d2-a8d5-2658e412e333 61 fields · synced Oct 6, 2026
- EUDAMED 7c8a8470-7bc1-4fc0-bb6c-bb07826f726d 61 fields · synced May 17, 2026
- EUDAMED b8b24bfb-ecbe-4cf1-a0ce-eeab89476125 61 fields · synced May 17, 2026
- EUDAMED 0a02cdae-6be5-41ed-a541-bcb4a9170d16 61 fields · synced May 18, 2026