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Monosteel

by Unisur Lifecare Private Limited India EUDAMED

Ref 16H70CX13Model 16B90DY20H

EMDN H010202010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890430012015ULSSS0134Q Basic UDI-DIDate4 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2025-MDR/QS-010/A Supplemented

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    8 Jan 2026
    Expires
    31 Jan 2030
    Reason
    Other

Specification

EUDAMED · synced 24 Oct 2026

Device Name
MONOFILAMENT STAINLESS STEEL 316 LVM Suture
Model / Reference
16B90DY20H, 16H70CX13
Primary DI / UDI-DI
08904300120968
Basic UDI-DI
890430012015ULSSS0134Q
EMDN Code
H010202010101 Stainless steel monofilament with needle
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
IN-MF-000008184
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
  • Sutures
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 8e6410fb-1ae1-425b-8c48-d0c3e2db2b98 61 fields · synced 24 Oct 2026