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Biotek

by Chetan Meditech Pvt. Ltd. India EUDAMED

Ref BAS-9120RModel Measurable Arthroscopy and Orthopaedic Instruments

EMDN L0299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2024-MDR/QS-040 Date1 Jul 2024IssuedStatusActive expires 1 Jul 2029

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

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

    Quality management system EU MDR

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

Specification

EUDAMED · synced 22 Oct 2026

Device Name
BIOTEK, Cannudrill, Flowertip, AI Reamer, Shuttleferry, Shuttleferry I, sHUTTLEFERRY II, Arthrovims OnLoc
Model / Reference
Measurable Arthroscopy and Orthopaedic Instruments, BAS-9120R
Primary DI / UDI-DI
18904210398591
Basic UDI-DI
89042103cmplins003YB
EMDN Code
L0299 Suture instruments, reusable - other
Device Class
Class I
Market of Registration
Germany

Manufacturer details

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

Other devices from Chetan Meditech Pvt. Ltd.

  • Biotek

    Class I
  • BUTTONFIX-F Mini

    Class IIb
  • Arthro Vims Anchor Lrt

    Class IIb
  • Arthro Vims Anchor Pk

    Class IIb
  • Arthro Vims Anchor Ti

    Class IIb
  • ONLoc

    Class I

See all devices from Chetan Meditech Pvt. Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
  • Measuring Function
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 2e5b0e72-b0a1-40dc-a6b8-89f6c82e61ce 61 fields · synced 22 Oct 2026