Skip to content

Biotek

by Chetan Meditech Pvt. Ltd. 296 variants

Ref 10716Model Measurable Arthroscopy and Orthopaedic Instruments

Active European Union

CE MDR

Valid until

1 Jul 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

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 Number89042103cmplins003YB Basic UDI-DI 18904210393688UDI-DIDate25 Apr 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2024-MDR/QS-040 Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    1 Jul 2024
    Expires
    1 Jul 2029

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
BIOTEK, Cannudrill, Flowertip, AI Reamer, Shuttleferry, Shuttleferry I, sHUTTLEFERRY II, Arthrovims OnLoc
Model / reference
Measurable Arthroscopy and Orthopaedic Instruments, 10716
Primary DI / UDI-DI
18904210393688
Basic UDI-DI
89042103cmplins003YB
EMDN code
L091001, L1999
Device class
Class I
EU registration type
Standard device
EU market of registration
France

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

  • Sterilise before use
  • Reusable
  • Measuring function

Other properties (11)

  • Supplied sterile: No
  • Implantable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Incorporates a medicinal substance: No