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Parietex PCOPM15H50

by Sofradim Production

Ref PCOPM15H50

Parietex PCOPM15H50 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 0763000B00014237M) with CE/MDR certificate MDR 729709 valid until 26 Feb 2029 and listed in FDA GUDID since 22 Oct 2015 (UDI-DI 10884521177772), active as of 23 Oct 2026.

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

CE MDR

Valid until

26 Feb 2029

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00014237M Basic UDI-DI 10884521177772UDI-DIDate20 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521177772 UDI-DI Date22 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00014237M registered 20 Jul 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10884521177772 listed 22 Oct 2015 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 729709 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    30 Jun 2026
    Expires
    26 Feb 2029
    Reason
    Change approved

Timeline

4 dated events

  1. Listed FDA GUDID 10884521177772
  2. Certificate issued EUDAMED MDR 729709
  3. Registered EUDAMED 0763000B00014237M
  4. Certificate expires EUDAMED MDR 729709

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  • Withdrawn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
ParietexTM EUDAMED
Parietex GUDID
Generic name
Extra-gynaecological surgical mesh, composite-polymer
Device name
Parietex Composite Parastomal mesh
Model / reference
PCOPM15H50
Primary DI / UDI-DI
10884521177772
Basic UDI-DI
0763000B00014237M
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
Size
Outer Diameter — 15 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)