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ONLoc

by Chetan Meditech Pvt. Ltd. 11 variants

Part of a family of 185 devices: see the family page

Ref BAK-7035-4Model Measurable Arthroscopy and Orthopaedic Instruments

ONLoc (BAK-7035-4) is a Class I device made by Chetan Meditech Pvt. Ltd., registered in EUDAMED on 25 Apr 2025 (Basic UDI-DI 89042103cmplins003YB) with CE/MDR certificate 2024-MDR/QS-040 valid until 1 Jul 2029, active as of 24 Oct 2026.

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

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89042103cmplins003YB Basic UDI-DI 18904210397426UDI-DIDate25 Apr 2025RegisteredStatusActive

Official records

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

Timeline

3 dated events

  1. Certificate issued EUDAMED 2024-MDR/QS-040
  2. Registered EUDAMED 89042103cmplins003YB
  3. Certificate expires EUDAMED 2024-MDR/QS-040

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  • Withdrawn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, BAK-7035-4
Primary DI / UDI-DI
18904210397426
Basic UDI-DI
89042103cmplins003YB
EMDN code
L0923, L1912
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

Similar devices in this category

Other devices filed under ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE.

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, all answered No)