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Neoprénová bandáž drieku
EUDAMEDClass I (EU MDR)
Ref J 22117Model Lumbosacral spine orthosesRef 8585003405981Model Lumbosacral orthose
Identity
- Trade Name
- Neoprénová bandáž drieku EUDAMEDNeoprénová bandáž drieku, PA-2 EUDAMED
- Model / Reference
- Lumbosacral spine orthoses EUDAMEDJ 22117 EUDAMEDLumbosacral orthose EUDAMED8585003405981 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003405981 EUDAMED
- Basic UDI-DI
- 858500J22117PA2SMHV EUDAMED
- Direct Marketing DI
- 08585003405981 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
Neoprénová bandáž drieku 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 | 858500J22117PA2SMHV | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (2)
- EUDAMED fcc43252-20cf-47e6-952a-ae316ced5ca6 61 fields · synced Jun 19, 2026
- EUDAMED 54506c12-dbf5-43d7-a8f9-4856c8c9e482 61 fields · synced Jun 14, 2026