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Parietex TEC1309

by Sofradim Production

Part of a family of 29 devices: see the family page

Ref TEC1309

Parietex TEC1309 is a device classified as Class III in the EU and Class II in the US made by Sofradim Production, registered in EUDAMED on 31 Jul 2026 (Basic UDI-DI 0763000B00003837T) with CE/MDR certificate MDR 729728 valid until 28 Jun 2031, cleared under FDA 510(k) K220586 on 22 Jun 2022 (1 earlier submission) and listed in FDA GUDID since 6 Oct 2015 (UDI-DI 10884521180093), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

28 Jun 2031

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) K220586

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00003837T Basic UDI-DI 10884521180093UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK220586 Date22 Jun 2022DecidedStatusActive
United StatesGUDID listing GUDID Number10884521180093 UDI-DI Date6 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00003837T registered 31 Jul 2026 Active· +1 more in the status table
  • FDA 510(k) K220586 decided 22 Jun 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10884521180093 listed 6 Oct 2015 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 729728 Active Reissued

    Technical documentation EU MDR

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

Timeline

6 dated events

  1. Cleared FDA 510(k) K982532
  2. Listed FDA GUDID 10884521180093
  3. Cleared FDA 510(k) K220586
  4. Certificate issued EUDAMED MDR 729728
  5. Registered EUDAMED 0763000B00003837T
  6. Certificate expires EUDAMED MDR 729728

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  • Withdrawn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
ParietexTM EUDAMED
Parietex GUDID
Generic name
Extra-gynaecological surgical mesh, composite-polymer
Device name
ParietexTM Hydrophylic 2D3D Anat. Mesh
Model / reference
TEC1309
Primary DI / UDI-DI
10884521180093
Basic UDI-DI
0763000B00003837T
510(k) Number
FDA product code
FTL
EMDN code
P900205 Polyester surgical meshes
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
Length — 13 Centimeter
Width — 9 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 (K220586)

and 8 more cleared under K220586

Cleared under the same submission (K982532)

and 8 more cleared under K982532

Similar devices in this category

Other devices filed under SURGICAL MESHES.

Other devices from Sofradim Production

See all devices from Sofradim Production →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)