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Unisynth

by Unisur Lifecare Private Limited 125 variants

Ref 10C125DZ40Model 10E90DZ30

Active European Union

CE MDR

Valid until

31 Jan 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890430012015ULSSS0104J Basic UDI-DI 08904300118057UDI-DIDate31 Jan 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 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/TD-005/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  • Withdrawn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

Device Name
Braided & Coated Polyglactin 910 Suture
Model / Reference
10E90DZ30, 10C125DZ40
Primary DI / UDI-DI
08904300118057
Basic UDI-DI
890430012015ULSSS0104J
EMDN Code
H010101020201 Polyglycolic with lactic acid multifilament with needle for open surgery
Device Class
Class III
EU market of registration
Lithuania

Manufacturer details

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

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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