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Non Sterile Gauze Compresses (Sponges)with XR

by Ağaoğlu Tıbbi Sağlık Tekstil San. ve Tic. A.Ş. 5 variants

Ref SN(NS)XRModel 7,5 CM X 18 CM 12 KAT XR LI, 6 CM X 25 CM XR LI, 7,5CMX22,5CM 8 KAT XR LI

Active European Union

CE MDD

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/MDD NumberB-08696921060265 Basic UDI-DI Date4 Apr 2024RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Ağaoğlu Gaz Kompres ( Spanç )
Model / Reference
7, 5 CM X 18 CM 12 KAT XR LI, SN(NS)XR, 6 CM X 25 CM XR LI, 5CMX22, 5CM 8 KAT XR LI
Primary DI / UDI-DI
08696921060265, 08696921064751, 08696921062764
Basic UDI-DI
B-08696921060265, B-08696921064751, B-08696921062764
EMDN Code
M0201020202 Cotton gauzes, folded, with x-ray detectable thread, non-sterile
Device Class
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000016023

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Properties

Other properties (11)

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