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Qubix-Pgcl

by Qubix Medicare Private Limited India EUDAMED

Ref QN 1205

EMDN H010101010301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890612217PGWB Basic UDI-DIDate17 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2026-MDR/QS-036 Issued

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    8 Jun 2026
    Expires
    2 Dec 2030
  • 2026-MDR/TD-036 Issued

    Technical documentation EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    8 Jun 2026
    Expires
    2 Dec 2030

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Monofilament Poliglecaprone 25 Suture
Model / Reference
QN 1205
Primary DI / UDI-DI
08906122170671
Basic UDI-DI
890612217PGWB
EMDN Code
H010101010301 Poliglecaprone and derivatives monofilament with needle
Device Class
Class III
Market of Registration
France

Manufacturer details

EUDAMED SRN
IN-MF-000042759
Authorised representative
Meddevices Lifesciences B.V. NL-AR-000000594

Other devices from Qubix Medicare Private Limited

  • WELKNIT-Composite Mesh

    Class III
  • Qubix-Polyglactin

    Class III
  • Welknit-3D Anatomical Mesh

    Class III
  • QUICKFIX Skin Glue

    Class IIa
  • WELKNIT -Mesh

    Class III
  • UBIX-Silk

    Class IIb

See all devices from Qubix Medicare Private Limited →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
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

Sources (1)

  • EUDAMED 08906122170671|890612217PGWB 61 fields · synced 24 Oct 2026