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Biotek

by Chetan Meditech Pvt. Ltd. India EUDAMED

Ref 10182Model Nonabsorbable Soft Tissue & Bone Fixation Device - Soft Tissue & Bone Fixation Screw EMDN P09120601,P09120603

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89042103cmplimp006XH 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  • Withdrawn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 · synced 25 Oct 2026

Device Name
Biotek, Softfix, Softfix-Pk
Model / Reference
Nonabsorbable Soft Tissue & Bone Fixation Device - Soft Tissue & Bone Fixation Screw, 10182
Primary DI / UDI-DI
18904210302741
Basic UDI-DI
89042103cmplimp006XH
EMDN Code
P09120601,P09120603
Device Class
Class IIb
Market of Registration
Poland

Manufacturer details

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

Other devices from Chetan Meditech Pvt. Ltd.

See all devices from Chetan Meditech Pvt. Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 18904210302741|89042103CMPLIMP006XH 61 fields · synced 25 Oct 2026