Skip to content

Xray'li Steri̇l Batin Kompres 45CMX45CM 12 Kat Tekli̇ Sterile Abdominal Compress with Xray 45CMX45CM 12 Ply Single

by Medi̇teks Sağlik Hi̇zmetleri̇ Tibbi̇ Malzeme Teksti̇l Ürünleri̇ San. Ve Diş Ti̇c. A.Ş.

Ref SBK97003

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86806210929UN Basic UDI-DI 08680621097003UDI-DIDate7 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Spanç-Ped-Gaz Kompres Sponge-Pad-Gas Compress
Model / Reference
SBK97003
Primary DI / UDI-DI
08680621097003
Basic UDI-DI
86806210929UN
EMDN Code
M0201030201 Laparotomy cotton gauzes, with x-ray detectable thread, sterile
Device Class
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000022021

Other devices from Medi̇teks Sağlik Hi̇zmetleri̇ Tibbi̇ Malzeme Teksti̇l Ürünleri̇ San. Ve Diş Ti̇c. A.Ş.

See all devices from Medi̇teks Sağlik Hi̇zmetleri̇ Tibbi̇ Malzeme Teksti̇l Ürünleri̇ San. Ve Diş Ti̇c. A.Ş. →

Properties

  • Sterile

Other properties (12)

  • 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