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Neoprénová bandáž kolena KO-2
EUDAMEDClass I (EU MDR)
Ref J 22128Model Knee orthose
Identity
- Trade Name
- Neoprénová bandáž kolena KO-2 EUDAMED
- Model / Reference
- Knee orthose EUDAMEDJ 22128 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003408432 EUDAMED08585003405752 EUDAMED08585003405769 EUDAMED08585003408418 EUDAMED
- Basic UDI-DI
- 858500J22128KO2XXL35 EUDAMED858500J22128KO2SDA EUDAMED858500J22128KO2MCW EUDAMED858500J22128KO2XLLK EUDAMED
- Direct Marketing DI
- 08585003408432 EUDAMED08585003405752 EUDAMED08585003405769 EUDAMED08585003408418 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
Neoprénová bandáž kolena KO-2 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 | 858500J22128KO2XXL35 | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (4)
- EUDAMED 869c1024-ab24-466e-9cbf-d15dcfed5a93 61 fields · synced Sep 18, 2026
- EUDAMED 553c9392-7c3e-4633-8767-93a9fbf7381c 61 fields · synced May 17, 2026
- EUDAMED 4e20bfaa-4b47-479d-b477-8d7e42abee06 61 fields · synced May 18, 2026
- EUDAMED ce8d5927-5113-4394-a37d-2cd0208414b7 61 fields · synced May 19, 2026