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Záves na zlomeninu HK
EUDAMEDClass I (EU MDR)
Ref J39799Model UpperRef J39798Model Shoulder orthosesRef J 39800
Identity
- Trade Name
- Záves na zlomeninu HK EUDAMED
- Device Name
- Shoulder orthoses EUDAMED
- Model / Reference
- Upper EUDAMEDJ39799 EUDAMEDShoulder orthoses EUDAMEDJ39798 EUDAMEDJ 39800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003404021 EUDAMED08585003404014 EUDAMED08585003404038 EUDAMED
- Basic UDI-DI
- 858500J39799ZAVHK2P4 EUDAMED858500J39798ZAVHK1NH EUDAMED858500J39800ZAVHK3DR EUDAMED
- Direct Marketing DI
- 08585003404021 EUDAMED08585003404014 EUDAMED08585003404038 EUDAMED
- EMDN Code
- Y060621 SHOULDER 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
Záves na zlomeninu HK 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 | 858500J39799ZAVHK2P4 | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (3)
- EUDAMED 11f16d34-c56f-4a55-8cdf-1c6bd621cdd7 61 fields · synced Aug 4, 2026
- EUDAMED 25dca1d8-aea6-4cee-97fe-7bf1bb4ca3f5 61 fields · synced May 17, 2026
- EUDAMED 02abfbc0-0bd2-4d2e-accf-decb0b3fcd4d 61 fields · synced May 17, 2026