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Parietene PP1510X3

by Sofradim Production

Ref PP1510X3

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 729726 Date29 Jun 2026IssuedStatusActive expires 28 Jun 2031
United StatesGUDID listing GUDID Number10884521179059 UDI-DI Date16 Jan 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 729726 Active Reissued Removed from EUDAMED

    Technical documentation EU MDR

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

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  • Withdrawn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
ParieteneTM EUDAMED
Parietene GUDID
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Device Name
ParieteneTM Flat Sheet Mesh
Model / Reference
PP1510X3
Primary DI / UDI-DI
10884521179059
Basic UDI-DI
0763000B00003827R
FDA Product Code
FTL
EMDN Code
P900202 Polypropylene 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 market of registration
France
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Width — 10 Centimeter
Length — 15 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Other devices from Sofradim Production

  • Parietene PP1515

    Class II

  • Parietene PP0611

    Class II

  • Parietene PP0611X3

    Class II

  • Parietene PP1510

    Class II

  • Parietene PP3030

    Class II

  • Parietene PP2020

    Class II

See all devices from Sofradim Production →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No