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Monosteel

by Unisur Lifecare Private Limited 14 variants

Ref 16B90DY20H, 16C100DZ50, 16E35AY60, 16G75CX20, 16F70DZ26, 16G45CX19, 16D150DZ30, 16G70CX16, 16E70DZ31, 16D70DZ31, 16C150DZ40, 16G45CY16, 16Q4x45DX50, 16F45DY48, 16H45CX13, 16D75DZ40, 16B90DY50H, 16F70CY25, 16F45CX19, 16B90DZ45, 16E75DZ30, 16C75DK40, 16F70CX26, 16C75CZ45, 16G45DY48, 16B75DK50, 16F90DY30, 16F45CY25, 16Q2x75DX60DA, 16D75DZ30, 16C90DY50H

Active European Union

CE MDR

Valid until

31 Jan 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890430012015ULSSS0134Q Basic UDI-DI Date4 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

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

    Quality management system EU MDR

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
MONOFILAMENT STAINLESS STEEL 316 LVM Suture
Model / Reference
16B90DY20H, 16C100DZ50, 16E35AY60, 16G75CX20, 16F70DZ26, 16G45CX19, 16D150DZ30, 16G70CX16, 16E70DZ31, 16D70DZ31, 16C150DZ40, 16G45CY16, 16Q4x45DX50, 16F45DY48, 16H45CX13, 16D75DZ40, 16B90DY50H, 16F70CY25, 16F45CX19, 16B90DZ45, 16E75DZ30, 16C75DK40, 16F70CX26, 16C75CZ45, 16G45DY48, 16B75DK50, 16F90DY30, 16F45CY25, 16Q2x75DX60DA, 16D75DZ30, 16C90DY50H
Primary DI / UDI-DI
08904300120906, 08904300121248, 08904300121071, 08904300139793, 08904300121019, 08904300120999, 08904300121200, 08904300120951, 08904300121033, 08904300121064, 08904300121217, 08904300120982, 08904300130745, 08904300139823, 08904300121095, 08904300121163, 08904300120937, 08904300121002, 08904300121118, 08904300121132, 08904300121149, 08904300126335, 08904300121040, 08904300121224, 08904300139830, 08904300126342, 08904300120913, 08904300121026, 08904300142489, 08904300121156, 08904300120920
Basic UDI-DI
890430012015ULSSS0134Q
EMDN Code
H010202010101 Stainless steel monofilament with needle
Device Class
Class IIb
EU market of registration
France

Manufacturer details

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

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Properties

  • 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