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Sterile abdominal gauze swabs with X-ray detectable thread, 45 cm x 45 cm, 4 la…
EUDAMEDClass IIa (EU MDR)
Ref 960950Model Sterile abdominal gauze swabs with X-ray detectable thread, 45 cm x 45 cm, 4 layers, 17 threads/cm2 with loop
Identity
- Trade Name
- Sterile abdominal gauze swabs with X-ray detectable thread, 45 cm x 45 cm, 4 layers, 17 threads/cm2 with loop EUDAMED
- Device Name
- Sterile abdominal gauze swabs with X-ray detectable thread, 45 cm x 45 cm, 4 layers, 17 threads/cm2 with loop EUDAMED
- Model / Reference
- Sterile abdominal gauze swabs with X-ray detectable thread, 45 cm x 45 cm, 4 layers, 17 threads/cm2 with loop EUDAMED960950 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08600099014548 EUDAMED
- Basic UDI-DI
- B-08600099014548 EUDAMED
- EMDN Code
- M0201020201 COTTON GAUZES, FOLDED, WITH X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovenia 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 abdominal gauze swabs with X-ray detectable thread, 45 cm x 45 cm, 4 la… by Niva Doo Žabalj — Class IIa — MDD — listed in EUDAMED
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-08600099014548 | Class IIa | 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 247ede89-661c-4258-ad34-e08001733e10 61 fields · synced Jul 30, 2026