Identity
- Trade Name
- NIVA PLASTER TAPE - silk, 5 cm x 5 m EUDAMED
- Device Name
- NIVA PLASTER TAPE - paper, silk, cotton EUDAMED
- Model / Reference
- 960609 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08600099004983 EUDAMED
- Basic UDI-DI
- 8600099FLASTERNAKALEMU8K EUDAMED
- Direct Marketing DI
- 08600099004983 EUDAMED
- EMDN Code
- M050101 PLASTERS ON SPOOLS (ROLLS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
NIVA PLASTER TAPE - silk, 5 cm x 5 m by Niva Doo Žabalj — 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 | 8600099FLASTERNAKALEMU8K | Class I | Active |
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Manufacturer
- Manufacturer
- Niva Doo Žabalj
- EUDAMED SRN
- RS-MF-000025025
- Authorised Representative
- Salus Cons Kft. HU-AR-000006177
Sources (1)
- EUDAMED 9a700219-2dbd-4016-a1e4-3aef18820771 61 fields · synced Jul 22, 2026