Skip to content

Unisynth

by Unisur Lifecare Private Limited 125 variants

Ref 10D45DZ40V, US2382, 9E70CY25, 9F45DZ30, 9D70DZ35, 10A75DX45, 9G70DZ17, 10E75DX48V, 10C90DR65DAV, 10I45BS8, 9E75DZ30, US2472, 10G45CZ16, 10E90DX26V, 9G70DZ15, US2404, 9H75DZ13, 10H75DZ16V, 9G45DZ20, 10C140DZDK40DA, 10E75DZ30V, 9B75DZ40, 10E90DZ48V, 9F70AZ60DA, 9B90DZ45, 10E75DZ40, 10C180DZDK5040, 9B150DZ50HL, 10D90DK36, 10G90CY16V, 10E70DZ40, 10D75DX48V, 9D75DZ30, N9262, 9B75DX40, 9G75CY20, 10B90DZ40V, 10I75DZ13V, 10F75DZ35, 10B75DZ50V, 10C70DZ40, 10C90CR65, 10H75CY16V, 10C90DZ40HV, 9G75CY19, 9E75DX26, 9D75DZ48, 9F90DZ30, 10D75DX48, 9F90DZ30DA, US2304Model 10E90DZ30, 9E70DZ25

Active European Union

CE MDR

Valid until

31 Jan 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

5 certificates

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 Number890430012015ULSSS0104J Basic UDI-DI Date31 Jan 2026RegisteredStatusActive

Certificates

5 certificates · EUDAMED

EUDAMED certificates (5)
  • 2025-MDR/QS-005/A Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    8 Jan 2026
    Expires
    31 Jan 2030
  • 2025-MDR/QS-007/A Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    8 Jan 2026
    Expires
    31 Jan 2030
  • 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
  • 2025-MDR/TD-005/A Active

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    8 Jan 2026
    Expires
    31 Jan 2030
  • 2025-MDR/TD-007/A Active

    Technical documentation EU MDR

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
Unisynth
Unisynth Pds
Device Name
Braided & Coated Polyglactin 910 Suture
Monofilament Polydioxanone Suture
Model / Reference
10E90DZ30, 10D45DZ40V, US2382, 9E70DZ25, 9E70CY25, 9F45DZ30, 9D70DZ35, 10A75DX45, 9G70DZ17, 10E75DX48V, 10C90DR65DAV, 10I45BS8, 9E75DZ30, US2472, 10G45CZ16, 10E90DX26V, 9G70DZ15, US2404, 9H75DZ13, 10H75DZ16V, 9G45DZ20, 10C140DZDK40DA, 10E75DZ30V, 9B75DZ40, 10E90DZ48V, 9F70AZ60DA, 9B90DZ45, 10E75DZ40, 10C180DZDK5040, 9B150DZ50HL, 10D90DK36, 10G90CY16V, 10E70DZ40, 10D75DX48V, 9D75DZ30, N9262, 9B75DX40, 9G75CY20, 10B90DZ40V, 10I75DZ13V, 10F75DZ35, 10B75DZ50V, 10C70DZ40, 10C90CR65, 10H75CY16V, 10C90DZ40HV, 9G75CY19, 9E75DX26, 9D75DZ48, 9F90DZ30, 10D75DX48, 9F90DZ30DA, US2304
Primary DI / UDI-DI
08904300134286, 08904300137591, 08904300116862, 08904300135252, 08904300116381, 08904300130851, 08904300127882, 08904300139588, 08904300139885, 08904300126618, 08904300112574, 08904300137621, 08904300127714, 08904300145176, 08904300138291, 08904300131247, 08904300135290, 08904300145299, 08904300135269, 08904300118965, 08904300134316, 08904300130981, 08904300145220, 08904300127875, 08904300135191, 08904300117807, 08904300118989, 08904300116886, 08904300118323, 08904300134385, 08904300127660, 08904300139540, 08904300116565, 08904300143059, 08904300139977, 08904300142359, 08904300136815, 08904300145343, 08904300118934, 08904300139564, 08904300117838, 08904300127622, 08904300134408, 08904300134279, 08904300144339, 08904300145718, 08904300127561, 08904300116374, 08904300130776, 08904300127868, 08904300137614
Basic UDI-DI
890430012015ULSSS0104J, 890430012015ULSSS0094Z
EMDN Code
H010101020201, H010101010101, H010201010101
Device Class
Class III
EU market of registration
Lithuania
France

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

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