Skip to content

Bi̇otex

by Bi̇otex Medi̇kal Teksti̇l İthalat İhracat San. Ve Ti̇c. a.ş 530 variants

Ref RMD-318-1

Active European Union

CE MDR CE MDD

Valid until

6 Feb 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier KIWA CERMET ITALIA S.P.A.

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 Number868181208GA1N8 Basic UDI-DI Date17 Oct 2025RegisteredStatusActive
European UnionCE/MDR Number868181208GA1N8 Basic UDI-DI Date17 Oct 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 00087-A Active

    Quality management system EU MDR

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Device Name
Sterile Drape
Hip U Drape
Model / Reference
RMD-318-1
Primary DI / UDI-DI
08681812080446, D-TRMF000023145RMD318174
Basic UDI-DI
868181208GA1N8, B-TRMF000023145RMD318174
EMDN Code
T020102, T0202
Device Class
Class I
EU 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

  • Bi̇otex

    Class I

See all devices from Bi̇otex Medi̇kal Teksti̇l İthalat İhracat San. Ve 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