Skip to content

Trulene Mesh TMM715

by Healthium Medtech Limited

Ref TMM715

Trulene Mesh TMM715 is an extra-gynaecological surgical mesh (EU MDR Class III; FDA Class II; FDA product code FTL, Mesh, Surgical, Polymeric) made by Healthium Medtech Limited, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 8903837P900202FY) with CE/MDR certificate 2022-MDR/QS-017/C valid until 15 Aug 2027 and listed in FDA GUDID since 11 Jul 2024 (UDI-DI 08903837067036), active as of 24 Oct 2026.

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

CE MDR

Valid until

15 Aug 2027

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

2 certificates

Certifier 3EC International a.s.

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8903837P900202FY Basic UDI-DI 08903837067036UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08903837067036 UDI-DI Date11 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8903837P900202FY registered 23 Sep 2026 Active· +2 more in the status table
  • FDA GUDID UDI-DI 08903837067036 listed 11 Jul 2024 Listed

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2022-MDR/QS-017/C Expiring Supplemented Expires in 273 days

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    10 Jul 2025
    Expires
    15 Aug 2027
    Reason
    Other
  • 2022-MDR/TD-017/C Expiring Supplemented Expires in 273 days

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    10 Jul 2025
    Expires
    15 Aug 2027
    Reason
    Other

Timeline

6 dated events

  1. Listed FDA GUDID 08903837067036
  2. Certificate issued EUDAMED 2022-MDR/QS-017/C
  3. Certificate issued EUDAMED 2022-MDR/TD-017/C
  4. Registered EUDAMED 8903837P900202FY
  5. Certificate expires EUDAMED 2022-MDR/QS-017/C
  6. Certificate expires EUDAMED 2022-MDR/TD-017/C

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Trulene Mesh
Generic name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Device name
Sterile Non-Absorbable Surgical Polypropylene Mesh
Model / reference
TMM715
Primary DI / UDI-DI
08903837067036
Basic UDI-DI
8903837P900202FY
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 registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

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, synthetic polymer, non-bioabsorbable

Similar devices in this category

Other devices filed under POLYPROPYLENE SURGICAL MESHES.

Other devices from Healthium Medtech Limited

See all devices from Healthium Medtech Limited →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)