Skip to content

Unilene Mesh

by Unisur Lifecare Private Limited 101 variants

Ref UM1515RSModel UM0611R2

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2025-MDR/QS-009/A Date8 Jan 2026IssuedStatusActive expires 31 Jan 2030

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2025-MDR/QS-009/A Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    8 Jan 2026
    Expires
    31 Jan 2030
  • 2025-MDR/TD-009/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  • Withdrawn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
Monofilament Polypropylene Mesh
Model / Reference
UM0611R2, UM1515RS
Primary DI / UDI-DI
08904300120616
Basic UDI-DI
890430012015ULSSM00137
EMDN Code
P900202 Polypropylene surgical meshes
Device Class
Class III
EU market of registration
Italy

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