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Neoprénová bandáž drieku
EUDAMEDClass I (EU MDR)
Ref J 22116Model Lumbosacral spine orthosesRef 8585003405554Model Lumbosacral orthose
Identity
- Trade Name
- Neoprénová bandáž drieku EUDAMEDNeoprénová bandáž drieku, PA-1 EUDAMED
- Model / Reference
- Lumbosacral spine orthoses EUDAMEDJ 22116 EUDAMEDLumbosacral orthose EUDAMED8585003405554 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003405554 EUDAMED
- Basic UDI-DI
- 858500J22116PA1XLHQ EUDAMED
- Direct Marketing DI
- 08585003405554 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 | 858500J22116PA1XLHQ | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (2)
- EUDAMED 814bda8f-8018-42f0-92a4-18e1c1e94eb0 61 fields · synced Jun 18, 2026
- EUDAMED 4688eedb-1a9c-4077-b129-c1de30682cd1 61 fields · synced Jun 18, 2026