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Bi̇otex

by Bi̇otex Medi̇kal Teksti̇l İthalat İhracat San. Ve Ti̇c. a.ş Türkiye EUDAMED

Ref RMD-334-1

EMDN T020102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number868181208GA1N8 Basic UDI-DIDate17 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 00087-A Issued

    Quality management system EU MDR

    Notified body
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    7 Feb 2025
    Expires
    6 Feb 2030

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Sterile Drape
Model / Reference
RMD-334-1
Primary DI / UDI-DI
08681812081023
Basic UDI-DI
868181208GA1N8
EMDN Code
T020102 Specialistic surgery drapes
Device Class
Class I
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000023145

Other devices from Bi̇otex Medi̇kal Teksti̇l İthalat İhracat San. Ve Ti̇c. a.ş

  • Bi̇otex

    Class I
  • Bi̇otex

    Class I
  • Bi̇otex

    Class I
  • Biotex

    Class I
  • Bi̇otex

    Class I
  • Biotex

    Class I

See all devices from Bi̇otex Medi̇kal Teksti̇l İthalat İhracat San. Ve Ti̇c. a.ş →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 3a803a07-4b0a-4e20-9e05-927b63c2e593 61 fields · synced 22 Oct 2026