Skip to content

Unisil

by Unisur Lifecare Private Limited 133 variants

Ref 5F70DY30, 5E45CZ27, 5G50DZ16DA, 8904300124638, 5D75DZ25, 5D75DZ30, 5F75DY35, 5J45CS6DA, 5E76DY30, 5G75CY15, 5D75DY45, 5A75DZ40, 5E75CX19, 5D75DY37, 5F75CY35, 5B75DY50, 5E45CX26, 5C50CX40, 5D75DZ37, 5C75DZ37, 5F90DZ35, 5D70DZ40, 5C50DZ48L, 5F90DZ26, 5E75DZ40, 5E90CX26, 5G75DY25, 5D70CX26, 5G70DZ16, 5F75CY15, 5F75EZ27, 5F70DZ25, 5G75DZ17, 5D70DZ25, 5E75CX25, 5D75CY30, 5F75DY24, 5F75CY26, 5E76DX50, 5H75DY16, 5F70CY35, 5C75DZ38, 5E90DX50, 5E45DZ26, 5F75DX17, 5E70DZ30, 5F75DZ40, 5F75DZ45, 5D90CX40, 5I75DY13

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 Number890430012015ULSSS0054R 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  • Withdrawn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

Trade Name
Unisil
Unisl
Device Name
Black Braided Silk Suture
Model / Reference
5F70DY30, 5E45CZ27, 5G50DZ16DA, 8904300124638, 5D75DZ25, 5D75DZ30, 5F75DY35, 5J45CS6DA, 5E76DY30, 5G75CY15, 5D75DY45, 5A75DZ40, 5E75CX19, 5D75DY37, 5F75CY35, 5B75DY50, 5E45CX26, 5C50CX40, 5D75DZ37, 5C75DZ37, 5F90DZ35, 5D70DZ40, 5C50DZ48L, 5F90DZ26, 5E75DZ40, 5E90CX26, 5G75DY25, 5D70CX26, 5G70DZ16, 5F75CY15, 5F75EZ27, 5F70DZ25, 5G75DZ17, 5D70DZ25, 5E75CX25, 5D75CY30, 5F75DY24, 5F75CY26, 5E76DX50, 5H75DY16, 5F70CY35, 5C75DZ38, 5E90DX50, 5E45DZ26, 5F75DX17, 5E70DZ30, 5F75DZ40, 5F75DZ45, 5D90CX40, 5I75DY13
Primary DI / UDI-DI
08904300124805, 08904300107662, 08904300124874, 08904300125000, 08904300109246, 08904300105996, 08904300130127, 08904300109543, 08904300105989, 08904300128063, 08904300137102, 08904300139762, 08904300109321, 08904300138864, 08904300142281, 08904300130004, 08904300145077, 08904300124768, 08904300138871, 08904300129824, 08904300135078, 08904300124829, 08904300125031, 08904300105484, 08904300129909, 08904300105453, 08904300130158, 08904300124485, 08904300124980, 08904300128032, 08904300124522, 08904300124706, 08904300129947, 08904300124935, 08904300104913, 08904300137119, 08904300128001, 08904300137867, 08904300137300, 08904300128445, 08904300137898, 08904300125017, 08904300139731, 08904300135047, 08904300124270, 08904300124461, 08904300124614, 08904300124379, 08904300124317, 08904300105439, 08904300130202
Basic UDI-DI
890430012015ULSSS0054R
EMDN Code
H010202020301 Silk with needle
Device Class
Class IIb
EU market of registration
Lithuania

Manufacturer details

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

Other devices from Unisur Lifecare Private Limited

  • Unilon

    Class IIb

  • Unilene

    Class IIb

  • Unibond

    Class IIb

  • Unisil

    Class IIb

  • i-Lon

    Class IIb

  • M-Glyde

    Class III

See all devices from Unisur Lifecare Private Limited →

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