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Biotex

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

Ref BİO-COVER

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-TRMF000023145BIOCOVER8H Basic UDI-DI D-TRMF000023145BIOCOVER8HUDI-DIDate9 Nov 2022RegisteredStatusActive

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  • Withdrawn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
Cover Ki̇te
Model / Reference
BİO-COVER
Primary DI / UDI-DI
D-TRMF000023145BIOCOVER8H
Basic UDI-DI
B-TRMF000023145BIOCOVER8H
EMDN Code
T0202 Surgical procedural kits (excluding surgical instrument kits)
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000023145

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

Properties

  • Sterile

Other properties (10)

  • 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