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Neoprénová bandáž drieku PA-1
EUDAMEDClass I (EU MDR)
Ref J 22116Model Lumbosacral spine orthosesRef 8585003405547Model Lumbosacral orthoseRef 8585003405561Ref 8585003405578
Identity
- Trade Name
- Neoprénová bandáž drieku PA-1 EUDAMEDNeoprénová bandáž drieku EUDAMEDNeoprénová bandáž drieku, PA-1 EUDAMED
- Model / Reference
- Lumbosacral spine orthoses EUDAMEDJ 22116 EUDAMEDLumbosacral orthose EUDAMED8585003405547 EUDAMED8585003405561 EUDAMED8585003405578 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003405585 EUDAMED08585003405561 EUDAMED08585003405578 EUDAMED08585003405547 EUDAMED
- Basic UDI-DI
- 858500J22116PA1XXSXS4J EUDAMED858500J22116PA1LAK EUDAMED858500J22116PA1SMHB EUDAMED858500J22116PA1XXLWD EUDAMED
- Direct Marketing DI
- 08585003405585 EUDAMED08585003405561 EUDAMED08585003405578 EUDAMED08585003405547 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 PA-1 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 | 858500J22116PA1XXSXS4J | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (7)
- EUDAMED f50d7ef1-3b4b-4a36-9b1c-5b30af047406 61 fields · synced Jul 12, 2026
- EUDAMED 7044679b-3516-4363-9f66-e5935f54a455 61 fields · synced May 16, 2026
- EUDAMED 6f72d3cd-1a80-4b66-a5da-e810def35667 61 fields · synced May 16, 2026
- EUDAMED e41e3be2-df10-49fc-95a7-cf798a867d1a 61 fields · synced May 17, 2026
- EUDAMED 5e49759c-90e5-46d2-8e68-27d60c076e1a 61 fields · synced Jul 9, 2026
- EUDAMED f70f601d-11a6-41b7-9cd6-830a2b465cbe 61 fields · synced Jul 12, 2026
- EUDAMED 6d5e17ea-f04c-43e8-8bd1-8ea95058d67a 61 fields · synced Jul 12, 2026