# Trulene Mesh TMM715

> Expiring: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/trulene-mesh-tmm715>
- Manufacturer: [Healthium Medtech Limited](https://devicerts.com/manufacturers/healthium-medtech-limited) (India)
- Device class: Class III (EU MDR); Class II (US FDA)
- FDA product code: FTL
- EMDN: P900202 POLYPROPYLENE SURGICAL MESHES
- GMDN: Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable (60300)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 8903837P900202FY · UDI-DI 08903837067036 · registered 2026-09-23 · status: Active
- **EUDAMED** · CE/MDR · European Union · 2022-MDR/QS-017/C · issued 2025-07-10 · expires 2027-08-15 · status: Expiring
- **EUDAMED** · CE/MDR · European Union · 2022-MDR/TD-017/C · issued 2025-07-10 · expires 2027-08-15 · status: Expiring
- **GUDID** · GUDID listing · United States · UDI-DI 08903837067036 · listed 2024-07-11 · status: Listed (GUDID: in commercial distribution)

## EU certificates

- 2022-MDR/QS-017/C · Quality management system · MDR · notified body 3EC International a.s. · issued 2025-07-10 · expires 2027-08-15 · status: supplemented
- 2022-MDR/TD-017/C · Technical documentation · MDR · notified body 3EC International a.s. · issued 2025-07-10 · expires 2027-08-15 · status: supplemented

## Recalls

No recall on record.

## Identity

- Trade name: Trulene Mesh [EUDAMED, FDA GUDID (AccessGUDID)]
- Generic name: Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable [FDA GUDID (AccessGUDID)]
- Device name: STERILE NON-ABSORBABLE SURGICAL POLYPROPYLENE MESH [EUDAMED]
- Model / reference: TMM715 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 08903837067036 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 8903837P900202FY [EUDAMED]
- FDA product code: FTL [FDA GUDID (AccessGUDID)]
- EMDN code: P900202 [EUDAMED]
- GMDN term: Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable (60300) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class III [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 878.3300 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Implantable: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Trulene Mesh TMM715, Healthium Medtech Limited. deviCERTS medical device catalogue. https://devicerts.com/devices/trulene-mesh-tmm715 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/trulene-mesh-tmm715.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/trulene-mesh-tmm715
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.