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Sterile gauze compress, 7.5 cm x 7.5 cm, 8 layers, 17 threads/cm2
EUDAMEDClass I (EU MDR)
Ref 960591Model Sterile gauze compress
Identity
- Trade Name
- Sterile gauze compress, 7.5 cm x 7.5 cm, 8 layers, 17 threads/cm2 EUDAMED
- Device Name
- Sterile gauze compress EUDAMED
- Model / Reference
- Sterile gauze compress EUDAMED960591 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08600099004242 EUDAMED
- Basic UDI-DI
- B-08600099004242 EUDAMED
- EMDN Code
- M0201020101 COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile gauze compress, 7.5 cm x 7.5 cm, 8 layers, 17 threads/cm2 by Niva Doo Žabalj — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08600099004242 | 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 4e3aab72-3583-495d-b774-bbc42d06f908 61 fields · synced Jun 19, 2026