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Parietex PCO6VP

by Sofradim Production

Ref PCO6VP

Parietex PCO6VP is a device classified as Class III in the EU and Class II in the US made by Sofradim Production, registered in EUDAMED on 10 Aug 2026 (Basic UDI-DI 0763000B000032175) with CE/MDR certificate MDR 729713 valid until 19 Sep 2027 and listed in FDA GUDID since 21 Oct 2016 (UDI-DI 10884521514157), expiring as of 25 Oct 2026.

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

CE MDR

Valid until

19 Sep 2027

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

2 certificates

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 729713 Date11 Aug 2026IssuedStatusExpiring expires 19 Sep 2027
United StatesGUDID listing GUDID Number10884521514157 UDI-DI Date21 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000032175 registered 10 Aug 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10884521514157 listed 21 Oct 2016 Listed

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • MDR 729713 Expiring Supplemented Expires in 310 days Removed from EUDAMED

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    30 Jun 2026
    Expires
    19 Sep 2027
    Reason
    Change approved
  • MDR 729713 Expiring Supplemented Expires in 310 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    11 Aug 2026
    Expires
    19 Sep 2027
    Reason
    Change approved

Timeline

4 dated events

  1. Listed FDA GUDID 10884521514157
  2. Registered EUDAMED 0763000B000032175
  3. Certificate issued EUDAMED MDR 729713
  4. Certificate expires EUDAMED MDR 729713

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ParietexTM EUDAMED
Parietex GUDID
Generic name
Extra-gynaecological surgical mesh, composite-polymer
Device name
ParietexTM Composite Ventral Patch
Model / reference
PCO6VP
Primary DI / UDI-DI
10884521514157
Basic UDI-DI
0763000B000032175
FDA product code
FTL
EMDN code
P900204 Surgical meshes, more than one component
GMDN term
Extra-gynaecological surgical mesh, composite-polymer
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
Outer Diameter — 6.6 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, composite-polymer

Similar devices in this category

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

Other devices from Sofradim Production

See all devices from Sofradim Production →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains animal tissues or cells
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)