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Biotek

by Chetan Meditech Pvt. Ltd. 44 variants

Ref 10164Model Nonabsorbable Soft Tissue & Bone Fixation Device - Soft Tissue & Bone Fixation Screw

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 Number89042103cmplimp006XH Basic UDI-DI 18904210302567UDI-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  • Withdrawn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, Softfix, Softfix-Pk
Model / Reference
Nonabsorbable Soft Tissue & Bone Fixation Device - Soft Tissue & Bone Fixation Screw, 10164
Primary DI / UDI-DI
18904210302567
Basic UDI-DI
89042103cmplimp006XH
EMDN Code
P09120601, P09120603
Device Class
Class IIb
EU 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

  • 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