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Niva non-sterile gauze compress 10 cm x 10 cm, 12 layers, 17 threads/cm2

by Niva Doo Žabalj

Ref 960537

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8600099NESTKOMPRESEGAZAWC Basic UDI-DI 08600099001074UDI-DIDate20 Nov 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Niva non-sterile gauze compress
Model / Reference
960537
Primary DI / UDI-DI
08600099001074
Basic UDI-DI
8600099NESTKOMPRESEGAZAWC
Direct Marketing DI
08600099001074
EMDN Code
M0201020102 Cotton gauzes, folded, without x-ray detectable thread, non-sterile
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
RS-MF-000025025
Authorised representative
Salus Cons Kft. HU-AR-000006177

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No