# Epitomee

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/epitomee-2tac-56>
- Manufacturer: [Epitomee Medical Ltd](https://devicerts.com/manufacturers/epitomee-medical-ltd) (Israel)
- Device class: Class IIb (EU MDR); Class II (US FDA)
- FDA product code: QFQ
- EMDN: G030699 DEVICES FOR THE NON-SURGICAL TREATMENT OF OBESITY - OTHER
- GMDN: Ingested gastric satiety device (48146)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 729001791400BU · UDI-DI 27290017914019 · registered 2026-04-08 · status: Active
- **EUDAMED** · CE/MDR · European Union · MDR 00055-A · issued 2026-03-17 · expires 2030-10-29 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 27290017914019 · listed 2025-04-22 · status: Listed (GUDID: in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K240544 · issued 2024-09-13 · status: Active

## EU certificates

- MDR 00055-A · Quality management system · MDR · notified body KIWA CERMET ITALIA S.P.A. · issued 2026-03-17 · expires 2030-10-29 · status: issued

## Recalls

No recall on record.

## Identity

- Generic name: Ingested gastric satiety device [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 6 [EUDAMED]; 2TAC- 56 [EUDAMED]; 6.6 [FDA GUDID (AccessGUDID)]; 2TAC-56 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 27290017914019 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 729001791400BU [EUDAMED]
- 510(k) Number: K240544 [FDA GUDID (AccessGUDID)]
- FDA product code: QFQ [FDA GUDID (AccessGUDID)]
- EMDN code: G030699 [EUDAMED]
- GMDN term: Ingested gastric satiety device (48146) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 876.5982 [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

- Single use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Implantable: 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]
- 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)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Epitomee, Epitomee Medical Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/epitomee-2tac-56 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/epitomee-2tac-56.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/epitomee-2tac-56
- 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.