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Unisynth

by Unisur Lifecare Private Limited 227 variants

Part of a family of 315 devices: see the family page

Ref 10F90DK36Model 10E90DZ30

Unisynth (10F90DK36) is a Class III device made by Unisur Lifecare Private Limited, registered in EUDAMED on 31 Jan 2026 (Basic UDI-DI 890430012015ULSSS0104J), active as of 7 Nov 2026.

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890430012015ULSSS0104J Basic UDI-DI 08904300118187UDI-DIDate31 Jan 2026RegisteredStatusActive

Official records

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  • Withdrawn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, 10F90DK36
Primary DI / UDI-DI
08904300118187
Basic UDI-DI
890430012015ULSSS0104J
EMDN code
H010101020201 Polyglycolic with lactic acid multifilament with needle for open surgery
Device class
Class III
EU registration type
Standard device
EU market of registration
Lithuania

Manufacturer details

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

Similar devices in this category

Other devices filed under POLYGLYCOLIC WITH LACTIC ACID MULTIFILAMENT WITH NEEDLE FOR OPEN SURGERY.

Other devices from Unisur Lifecare Private Limited

See all devices from Unisur Lifecare Private Limited →

Properties

  • Supplied sterile
  • Implantable
Other properties (12, all answered No)