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Bandáž napomínacia, gumotextil, typ III
EUDAMEDClass I (EU MDR)
Ref J 22160Model Non-extremity prostheses - otherModel Non - extremity prostheses - otherRef 8585003406308Model Non-extremity orthoseRef 8585003406261Ref 8585003406285Ref 8585003406254Ref 8585003408753
Identity
- Trade Name
- Bandáž napomínacia, gumotextil, typ III EUDAMED
- Model / Reference
- Non-extremity prostheses - other EUDAMEDJ 22160 EUDAMEDNon - extremity prostheses - other EUDAMEDNon-extremity orthose EUDAMED8585003406308 EUDAMED8585003406261 EUDAMED8585003406285 EUDAMED8585003406254 EUDAMED8585003408753 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003406254 EUDAMED08585003406308 EUDAMED08585003406261 EUDAMED08585003406285 EUDAMED08585003408753 EUDAMED
- Basic UDI-DI
- 858500J22160IIIXSMB EUDAMED858500J22160IIIXXL37 EUDAMED858500J22160IIISCU EUDAMED858500J22160IIILCE EUDAMED858500J22160IIIXXXLPC EUDAMED
- Direct Marketing DI
- 08585003406254 EUDAMED08585003406308 EUDAMED08585003406261 EUDAMED08585003406285 EUDAMED08585003408753 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, gumotextil, typ III 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 | 858500J22160IIIXSMB | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (10)
- EUDAMED 8be8e2b9-c603-495a-8095-18f461db2d6d 61 fields · synced Oct 5, 2026
- EUDAMED daf63470-d8fa-438f-9dc7-2d434dc8b4c3 61 fields · synced May 16, 2026
- EUDAMED 9d7b09cb-265f-4f63-8249-d2714c91a16f 61 fields · synced May 17, 2026
- EUDAMED 4f0167c0-7e67-4e7b-b950-54f762adf3a8 61 fields · synced May 19, 2026
- EUDAMED 5f37e261-72bc-4cee-b7a9-107d8cff42ed 61 fields · synced May 19, 2026
- EUDAMED 28eb6ec8-507d-4fc1-91d6-81f947377f5f 61 fields · synced Jul 21, 2026
- EUDAMED f9120e51-f234-477f-80b8-bcea0e08d2bd 61 fields · synced Jul 24, 2026
- EUDAMED c96528af-42e9-4ebb-b50b-0f076d875593 61 fields · synced Jul 26, 2026
- EUDAMED 3106e483-257b-4785-b77e-26534f791ffc 61 fields · synced Aug 5, 2026
- EUDAMED 72010114-2147-4a2d-90be-7988582c3f9f 61 fields · synced Aug 5, 2026