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GalaFLEX 3D

by Tepha Inc. 3 variants

Ref CESH01Model GalaFLEX 3D

GalaFLEX 3D (CESH01) is a Class III device made by Tepha, Inc., registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI B-0081005498040LCL), active as of 7 Nov 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-0081005498040LCL Basic UDI-DI D-0081005498040LCLUDI-DIDate20 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
GalaFLEX 3D Scaffold
Model / reference
GalaFLEX 3D, CESH01
Primary DI / UDI-DI
D-0081005498040LCL
Basic UDI-DI
B-0081005498040LCL
EMDN code
P900299 Surgical meshes - other
Device class
Class III
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000008279
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under SURGICAL MESHES - OTHER.

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Properties

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