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Uniglyde Mono

by Unisur Lifecare Private Limited 58 variants

Ref 11E75DZ37, 11F75CX24, 2E75DZ30V, 11G70CX16, 11G75CY18, 2E75CY24V, 2A90DZ65V, 11C152DZ40, 11B90DZ45, 11C76CZ45, 11H75CX18U, 11H70CX13, 11D76DZ30, 11G45CY16, 11C100DZ50, 2G75DZ20V, 2D75DZ38V, 11F45CY25, 2G75DZ18V, 11D75DZ40, 11D150DZ30, 2F75DY19V, 11H75DX22U, 11E75DY36H, 11F75DX22U, N4246MVS, 11F75CY20, 11F75DZ22, 2E75DY26V, 2H75DY16V, 2I75DZ10V, 11F70CX26, 11H45CX13, N1326, 2C75DZ50V, 11F75DX19U, 11E70DZ30, 2C75DY36V, 11F70CY25, 11F45CX19, 11G70CX19, 11F45CX45, 2B90DR40V, 11G75CX16U, 11E70DX36, 11F70CX25, 11H75CX19, 11H75CY19, N1665, 2C75DR48V, 2C90DX48VModel 11F70CX20, 2D70DZ30

Active European Union

CE MDR

Valid until

31 Jan 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

4 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 Number2025-MDR/QS-004/A Date8 Jan 2026IssuedStatusActive expires 31 Jan 2030

Certificates

4 certificates · EUDAMED

EUDAMED certificates (4)
  • 2025-MDR/QS-004/A Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    8 Jan 2026
    Expires
    31 Jan 2030
  • 2025-MDR/QS-006/A Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    8 Jan 2026
    Expires
    31 Jan 2030
  • 2025-MDR/TD-004/A Active

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    8 Jan 2026
    Expires
    31 Jan 2030
  • 2025-MDR/TD-006/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  • Withdrawn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
Uniglyde Mono
Uniglyde
Device Name
Monofilament Poliglecaprone 25 Suture
Braided & Coated Polyglycolic Acid Suture
Model / Reference
11F70CX20, 11E75DZ37, 11F75CX24, 2D70DZ30, 2E75DZ30V, 11G70CX16, 11G75CY18, 2E75CY24V, 2A90DZ65V, 11C152DZ40, 11B90DZ45, 11C76CZ45, 11H75CX18U, 11H70CX13, 11D76DZ30, 11G45CY16, 11C100DZ50, 2G75DZ20V, 2D75DZ38V, 11F45CY25, 2G75DZ18V, 11D75DZ40, 11D150DZ30, 2F75DY19V, 11H75DX22U, 11E75DY36H, 11F75DX22U, N4246MVS, 11F75CY20, 11F75DZ22, 2E75DY26V, 2H75DY16V, 2I75DZ10V, 11F70CX26, 11H45CX13, N1326, 2C75DZ50V, 11F75DX19U, 11E70DZ30, 2C75DY36V, 11F70CY25, 11F45CX19, 11G70CX19, 11F45CX45, 2B90DR40V, 11G75CX16U, 11E70DX36, 11F70CX25, 11H75CX19, 11H75CY19, N1665, 2C75DR48V, 2C90DX48V
Primary DI / UDI-DI
08904300127172, 08904300127196, 08904300144186, 08904300111669, 08904300106634, 08904300144278, 08904300144254, 08904300112307, 08904300111751, 08904300112314, 08904300145787, 08904300111348, 08904300111775, 08904300127912, 08904300111638, 08904300129428, 08904300137287, 08904300112918, 08904300144148, 08904300111553, 08904300111591, 08904300129619, 08904300145794, 08904300106597, 08904300145763, 08904300143189, 08904300106603, 08904300106627, 08904300129565, 08904300129749, 08904300129435, 08904300111508, 08904300111478, 08904300139151, 08904300129503, 08904300139960, 08904300111430, 08904300129480, 08904300111676, 08904300111492, 08904300103916, 08904300103015, 08904300143516, 08904300136891, 08904300103886, 08904300130455, 08904300127226, 08904300107884, 08904300143608, 08904300129367, 08904300143509
Basic UDI-DI
890430012015ULSSS0114L, 890430012015ULSSS0024K
EMDN Code
H010101010301, H010101020101
Device Class
Class III
EU market of registration
Greece
Malta
Romania
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

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