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Niva non-sterile gauze compress 15 cm x 7 cm, 16 layers, 17 threads/cm2
EUDAMEDClass I (EU MDR)
Ref 960574
Identity
- Trade Name
- Niva non-sterile gauze compress 15 cm x 7 cm, 16 layers, 17 threads/cm2 EUDAMED
- Device Name
- Niva non-sterile gauze compress EUDAMED
- Model / Reference
- 960574 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08600099000978 EUDAMED
- Basic UDI-DI
- 8600099NESTKOMPRESEGAZAWC EUDAMED
- Direct Marketing DI
- 08600099000978 EUDAMED
- EMDN Code
- M0201020102 COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 non-sterile gauze compress 15 cm x 7 cm, 16 layers, 17 threads/cm2 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 | 8600099NESTKOMPRESEGAZAWC | 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 ff544a28-0ccb-4f2c-b48e-fad625aad053 61 fields · synced Oct 5, 2026