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Ortéza lakťa s dlahami, Sohatex, LA-32
EUDAMEDClass I (EU MDR)
Ref J 80832Model Elbow orthose with splintsRef 8585003406087Ref 8585003406070Model Elbow orthose with splints
Identity
- Trade Name
- Ortéza lakťa s dlahami,Sohatex, LA-32 EUDAMEDOrtéza lakťa s dlahami, Sohatex, LA-32 EUDAMED
- Model / Reference
- Elbow orthose with splints EUDAMEDJ 80832 EUDAMED8585003406087 EUDAMED8585003406070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003406087 EUDAMED08585003406070 EUDAMED
- Basic UDI-DI
- 858500J80832LA32LLS EUDAMED858500J80832LA32MLU EUDAMED
- Direct Marketing DI
- 08585003406087 EUDAMED08585003406070 EUDAMED
- EMDN Code
- Y060615 ELBOW 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
Ortéza lakťa s dlahami, Sohatex, LA-32 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 | 858500J80832LA32LLS | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (4)
- EUDAMED 336aab87-4477-49ca-8e04-6238c4c1036e 61 fields · synced Jul 29, 2026
- EUDAMED b0fe255c-b3bd-4198-addb-dd6d4453be1b 61 fields · synced May 17, 2026
- EUDAMED e371ee1d-7653-40b4-bfd2-4b881c8f8701 61 fields · synced Jul 15, 2026
- EUDAMED 08ff6cbc-403f-4a30-b9f6-d89f5f98b2c9 61 fields · synced Jul 29, 2026