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Non Sterile Lap Sponges with XR

by Ağaoğlu Tıbbi Sağlık Tekstil San. ve Tic. A.Ş. 3 variants

Ref BK(NS)XRModel 45CMX45CM 8 KAT XR'LI TEKLİ PAKET, 45CMX45CM 12 KAT XR Lİ, 45CMX45CM 8 KAT XR LI, 35CMX35CM 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08696921064270 Basic UDI-DI Date13 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  • Withdrawn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 Batin Kompres
Model / Reference
45CMX45CM 8 KAT XR'LI TEKLİ PAKET, BK(NS)XR, 45CMX45CM 12 KAT XR Lİ, 45CMX45CM 8 KAT XR LI, 35CMX35CM 8 KAT XR'LI
Primary DI / UDI-DI
08696921064270, 08696921061392, 08696921060548, 08696921064577
Basic UDI-DI
B-08696921064270, B-08696921061392, B-08696921060548, B-08696921064577
EMDN Code
M0201030202 Laparotomy cotton gauzes, 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