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4DMESH®

by Cousin Biotech 8 variants

Part of a family of 47 devices: see the family page

Ref FBIOSRF128

4DMESH® (FBIOSRF128) is a Class III device made by Cousin Biotech, registered in EUDAMED on 8 Feb 2026 (Basic UDI-DI 3760185574DMESH5V) with CE/MDR certificate 1000298945 valid until 29 Sep 2030, active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

29 Sep 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000298945 Date7 May 2026IssuedStatusActive expires 29 Sep 2030

Official records

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000298945 Active Supplemented

    Technical documentation EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    7 May 2026
    Expires
    29 Sep 2030
    Reason
    Change approved
  • 1000299303 Active Supplemented

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    7 May 2026
    Expires
    29 Sep 2030
    Reason
    Change approved

Timeline

5 dated events

  1. Registered EUDAMED 3760185574DMESH5V
  2. Certificate issued EUDAMED 1000298945
  3. Certificate issued EUDAMED 1000299303
  4. Certificate expires EUDAMED 1000298945
  5. Certificate expires EUDAMED 1000299303

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Sterile Semi-Resorbable Parietal Reinforcement Implants
Model / reference
FBIOSRF128
Primary DI / UDI-DI
03760185571258
Basic UDI-DI
3760185574DMESH5V
EMDN code
P900204 Surgical meshes, more than one component
Device class
Class III
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000001179

Similar devices in this category

Other devices filed under SURGICAL MESHES, MORE THAN ONE COMPONENT.

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Properties

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