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Gumotextilná bandáž pásová
EUDAMEDClass I (EU MDR)
Ref J 53675Model Lumbosacral spine orthosesRef 8585003409385Model Lumbosacral orthose
Identity
- Trade Name
- Gumotextilná bandáž pásová EUDAMEDGumotextilná bandáž pásová, PA-21 EUDAMED
- Model / Reference
- Lumbosacral spine orthoses EUDAMEDJ 53675 EUDAMEDLumbosacral orthose EUDAMED8585003409385 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003409385 EUDAMED
- Basic UDI-DI
- 858500J53675PA21XXSXSY2 EUDAMED
- Direct Marketing DI
- 08585003409385 EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE 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
Gumotextilná bandáž pásová 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 | 858500J53675PA21XXSXSY2 | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (2)
- EUDAMED fd0e75fc-5e46-468e-baf8-d564a2e6e52a 61 fields · synced Jul 9, 2026
- EUDAMED 45a4433d-c5ed-4de6-8795-260f6a12deec 61 fields · synced Jul 9, 2026