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Biotek

by Chetan Meditech Pvt. Ltd. India EUDAMED

Ref 10130Model Single Use Arthroscopy and Orthopaedic Instruments - Suture Passing Instruments

EMDN H900899

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89042103cmplins001Y7 Basic UDI-DIDate24 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Biotek, Arthrrovims
Model / Reference
Single Use Arthroscopy and Orthopaedic Instruments - Suture Passing Instruments, 10130
Primary DI / UDI-DI
18904210396573
Basic UDI-DI
89042103cmplins001Y7
EMDN Code
H900899 Single-use instruments for sutures - other
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

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

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  • ONLoc

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • 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 17de026f-9fcd-4c43-b6bd-cfc228be857e 61 fields · synced 22 Oct 2026