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Bandáž napomínacia, guma, typ I
EUDAMEDClass I (EU MDR)
Ref J 39793Model Non-extremity prostheses-otherRef J 39792Model Non-extremity prostheses - otherRef J 39794Ref 8585003403420Model Non-extremity orthoseRef 8585003403413Model Non - extremity orthoseRef 8585003403437
Identity
- Trade Name
- Bandáž napomínacia,guma,typ I EUDAMEDBandáž napomínacia,guma, typ I EUDAMEDBandáž napomínacia, guma, typ I EUDAMED
- Model / Reference
- Non-extremity prostheses-other EUDAMEDJ 39793 EUDAMEDNon-extremity prostheses - other EUDAMEDJ 39792 EUDAMEDJ 39794 EUDAMEDNon-extremity orthose EUDAMED8585003403420 EUDAMEDNon - extremity orthose EUDAMED8585003403413 EUDAMED8585003403437 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003403420 EUDAMED08585003403413 EUDAMED08585003403437 EUDAMED
- Basic UDI-DI
- 858500J39793I2F8 EUDAMED858500J39792I1EZ EUDAMED858500J39794I3FF EUDAMED
- Direct Marketing DI
- 08585003403420 EUDAMED08585003403413 EUDAMED08585003403437 EUDAMED
- EMDN Code
- Y063099 NON-EXTREMITY PROSTHESES - OTHER 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
Bandáž napomínacia, guma, typ I 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 | 858500J39793I2F8 | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (6)
- EUDAMED c6f2e30b-0647-4570-8417-03c6c6e85570 61 fields · synced Sep 18, 2026
- EUDAMED 6c4295e6-e933-426f-86ee-6d262f8d9191 61 fields · synced May 18, 2026
- EUDAMED 8e942dfb-fa9b-4140-8161-72026e077f80 61 fields · synced May 18, 2026
- EUDAMED a8191685-7dc7-48c4-ac6d-2ac5b9c0a5fc 61 fields · synced Jul 9, 2026
- EUDAMED da6ff0d2-9800-4ed7-b33e-836628e0d03c 61 fields · synced Jul 13, 2026
- EUDAMED 9f4741c2-ba65-4097-8b74-3a095f03d99c 61 fields · synced Sep 18, 2026