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Parietene DS PPDS2015X3

by Sofradim Production

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

Ref PPDS2015X3

Parietene DS PPDS2015X3 is a device classified as Class III in the EU and Class II in the US made by Sofradim Production, registered in EUDAMED on 27 May 2026 (Basic UDI-DI 0763000B000112172) with CE/MDR certificate MDR 729720 valid until 20 Feb 2028, cleared under FDA 510(k) K163212 on 29 Jun 2017 and listed in FDA GUDID since 26 Jan 2020 (UDI-DI 10884521784123), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

CE MDR 510(k)

Valid until

20 Feb 2028

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

510(k) K163212

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 729720 Date23 Sep 2026IssuedStatusActive expires 20 Feb 2028
United StatesGUDID listing GUDID Number10884521784123 UDI-DI Date26 Jan 2020ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK163212 Date29 Jun 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000112172 registered 27 May 2026 Active· +1 more in the status table
  • FDA 510(k) K163212 decided 29 Jun 2017 Active
  • FDA GUDID UDI-DI 10884521784123 listed 26 Jan 2020 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 729720 Restricted

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    23 Sep 2026
    Expires
    20 Feb 2028
    Reason
    Not on market

Timeline

5 dated events

  1. Cleared FDA 510(k) K163212
  2. Listed FDA GUDID 10884521784123
  3. Registered EUDAMED 0763000B000112172
  4. Certificate issued EUDAMED MDR 729720
  5. Certificate expires EUDAMED MDR 729720

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
ParieteneTM EUDAMED
Parietene DS GUDID
Generic name
Extra-gynaecological surgical mesh, composite-polymer
Device name
Parietene DS Composite Mesh
Model / reference
PPDS2015X3
Primary DI / UDI-DI
10884521784123
Basic UDI-DI
0763000B000112172
510(k) Number
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
Not in Commercial Distribution
MRI safety
MR Safe
Size
Width — 20 Centimeter
Length — 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

Cleared under the same submission (K163212)

and 8 more cleared under K163212

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