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Versatex VTX1510X3

by Sofradim Production

Part of a family of 11 devices: see the family page

Ref VTX1510X3

Versatex VTX1510X3 is a device classified as Class III in the EU and Class II in the US made by Sofradim Production, registered in EUDAMED on 20 Jul 2026 (Basic UDI-DI 0763000B00003847V) with CE/MDR certificate MDR 729727 valid until 28 Jun 2031 and listed in FDA GUDID since 15 Apr 2016 (UDI-DI 10884521532625), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

28 Jun 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00003847V Basic UDI-DI 10884521532625UDI-DIDate20 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521532625 UDI-DI Date15 Apr 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00003847V registered 20 Jul 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10884521532625 listed 15 Apr 2016 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 729727 Active Reissued

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    29 Jun 2026
    Expires
    28 Jun 2031

Timeline

4 dated events

  1. Listed FDA GUDID 10884521532625
  2. Certificate issued EUDAMED MDR 729727
  3. Registered EUDAMED 0763000B00003847V
  4. Certificate expires EUDAMED MDR 729727

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
VersatexTM EUDAMED
Versatex GUDID
Generic name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Device name
VersatexTM Monofilament Mesh
Model / reference
VTX1510X3
Primary DI / UDI-DI
10884521532625
Basic UDI-DI
0763000B00003847V
FDA product code
FTL
EMDN code
P900205 Polyester surgical meshes
GMDN term
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Device class
Class III EUDAMED
Class II GUDID
Regulation number
878.3300
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Length — 15 Centimeter
Width — 10 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

Similar devices in this category

Other devices filed under SURGICAL MESHES.

Other devices from Sofradim Production

See all devices from Sofradim Production →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)