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Epitomee

by Epitomee Medical Ltd 2 variants

Ref 2TAC- 14Model 6,6

Epitomee (2TAC- 14) is an ingested gastric satiety device (EU MDR Class IIb; FDA Class II; FDA product code QFQ) made by Epitomee Medical Ltd, registered in EUDAMED on 8 Apr 2026 (Basic UDI-DI 729001791400BU) with CE/MDR certificate MDR 00055-A valid until 29 Oct 2030, cleared under FDA 510(k) K240544 on 13 Sep 2024 and listed in FDA GUDID since 22 Apr 2025 (UDI-DI 27290017914026), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

29 Oct 2030

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier KIWA CERMET ITALIA S.P.A.

510(k) K240544

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729001791400BU Basic UDI-DI 27290017914026UDI-DIDate8 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number27290017914026 UDI-DI Date22 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK240544 Date13 Sep 2024IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 729001791400BU registered 8 Apr 2026 Active· +1 more in the status table
  • FDA 510(k) K240544 decided 13 Sep 2024 Active
  • FDA GUDID UDI-DI 27290017914026 listed 22 Apr 2025 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 00055-A Active

    Quality management system EU MDR

    Certifier
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    17 Mar 2026
    Expires
    29 Oct 2030

Timeline

5 dated events

  1. Cleared FDA 510(k) K240544
  2. Listed FDA GUDID 27290017914026
  3. Certificate issued EUDAMED MDR 00055-A
  4. Registered EUDAMED 729001791400BU
  5. Certificate expires EUDAMED MDR 00055-A

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  • Withdrawn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

Generic name
Ingested gastric satiety device
Model / Ref / Catalog
6 EUDAMED
2TAC- 14 EUDAMED
6.6 GUDID
2TAC-14 GUDID
Primary DI / UDI-DI
27290017914026
Basic UDI-DI
729001791400BU
510(k) Number
FDA product code
QFQ
EMDN code
G030699 Devices for the non-surgical treatment of obesity - other
GMDN term
Ingested gastric satiety device
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.5982
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
6,6
2TAC- 14
GUDID
6.6
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
IL-MF-000018148
Authorised representative
MedNet EC-REP IIb GmbH DE-AR-000011192

Similar devices in this category

Other devices filed under GASTROINTESTINAL ENDOSCOPY DEVICES.

Other devices from Epitomee Medical Ltd

  • Epitomee

    Class IIb

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)