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ProGrip PP2015G

by Sofradim Production

Part of a family of 8 devices: see the family page

Ref PP2015G

ProGrip PP2015G is a device classified as Class III in the EU and Class II in the US made by Sofradim Production, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 0763000B00003867Z), cleared under FDA 510(k) K243315 on 17 Jan 2025 (1 earlier submission) and listed in FDA GUDID since 4 Feb 2024 (UDI-DI 10884521844285), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

19 Sep 2027

CE MDR certificate

FDA recalls

None found

in data synced 7 Nov 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

510(k) K243315

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00003867Z Basic UDI-DI 10884521844285UDI-DIDate28 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK243315 Date17 Jan 2025DecidedStatusActive
United StatesGUDID listing GUDID Number10884521844285 UDI-DI Date4 Feb 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00003867Z registered 28 May 2026 Active
  • FDA 510(k) K243315 decided 17 Jan 2025 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10884521844285 listed 4 Feb 2024 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 729715 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. Cleared FDA 510(k) K232373
  2. Listed FDA GUDID 10884521844285
  3. Cleared FDA 510(k) K243315
  4. Registered EUDAMED 0763000B00003867Z

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  • Withdrawn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
ProGripTM EUDAMED
ProGrip GUDID
Generic name
Extra-gynaecological surgical mesh, composite-polymer
Device name
Progrip Self-Gripping Polypropylene Mesh
Model / reference
PP2015G
Primary DI / UDI-DI
10884521844285
Basic UDI-DI
0763000B00003867Z
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
In Commercial Distribution
MRI safety
MR Safe
Size
Width — 15 Centimeter
Length — 20 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 (K232373)

Cleared under the same submission (K243315)

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
Other properties (19, all answered No)