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Bandáž napomínacia, gumotextil, typ II
EUDAMEDClass I (EU MDR)
Ref J 39795Model Non-extremity prostheses -otherRef 8585003403444Model Non-extremity orthose
Identity
- Trade Name
- Bandáž napomínacia, gumotextil, typ II EUDAMED
- Model / Reference
- Non-extremity prostheses -other EUDAMEDJ 39795 EUDAMEDNon-extremity orthose EUDAMED8585003403444 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003403444 EUDAMED
- Basic UDI-DI
- 858500J39795II1FY EUDAMED
- Direct Marketing DI
- 08585003403444 EUDAMED
- EMDN Code
- Y063099 NON-EXTREMITY PROSTHESES - OTHER 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
Bandáž napomínacia, gumotextil, typ II 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 | 858500J39795II1FY | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (2)
- EUDAMED 2cf45757-79a3-48da-9169-7e8e21b07c0f 61 fields · synced Jun 18, 2026
- EUDAMED c807b899-ae62-4de6-9b14-ba419fc02e67 61 fields · synced Jun 11, 2026