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BioFiber

by Chetan Meditech Pvt. Ltd. EUDAMED

Active European Union

Ref 10206Model Nonabsorbable Soft Tissue & Bone Fixation Device - Sutures and Tapes

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89042103cmplimp007XK Basic UDI-DIDate16 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
BIOTEK, BioFiber
Model / Reference
Nonabsorbable Soft Tissue & Bone Fixation Device - Sutures and Tapes, 10206
Primary DI / UDI-DI
18904210304486
Basic UDI-DI
89042103cmplimp007XK
EMDN Code
H0102010299 Synthetic nonabsorbable multifilament sutures - other
Device Class
Class IIb
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
IN-MF-000013541
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Related devices

Category: Polyester suture, non-bioabsorbable, multifilament

Other devices from Chetan Meditech Pvt. Ltd.

See all devices from Chetan Meditech Pvt. Ltd. →

Properties

  • Sterile
  • Implantable
  • Sutures

Other properties (11)

  • 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