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BioFiber

by Chetan Meditech Pvt. Ltd. 33 variants

Ref BF-16BSTModel Nonabsorbable Soft Tissue & Bone Fixation Device - Sutures and Tapes

Active European Union

CE MDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89042103cmplimp007XK Basic UDI-DI 18904210301331UDI-DIDate16 Apr 2025RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
BIOTEK, BioFiber
Model / Reference
Nonabsorbable Soft Tissue & Bone Fixation Device - Sutures and Tapes, BF-16BST
Primary DI / UDI-DI
18904210301331
Basic UDI-DI
89042103cmplimp007XK
EMDN Code
H0102010299 Synthetic nonabsorbable multifilament sutures - other
Device Class
Class IIb
EU market of registration
Greece

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