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Sanrotex Medical

by Bandtex Grup S.R.L. Romania EUDAMED

Ref BTX101008100Model BTX4040100

EMDN M0201020102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5944792NSTERGAUZESWABS1MR Basic UDI-DIDate27 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Gauze Swabs
Model / Reference
BTX4040100, BTX101008100
Primary DI / UDI-DI
05944792000020
Basic UDI-DI
5944792NSTERGAUZESWABS1MR
EMDN Code
M0201020102 Cotton gauzes, folded, without x-ray detectable thread, non-sterile
Device Class
Class I
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
RO-MF-000004081

Other devices from Bandtex Grup S.R.L.

See all devices from Bandtex Grup S.R.L. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED fbbb47d6-602f-4bd0-90a1-7e8e6e9cd342 61 fields · synced 22 Oct 2026