Identity
- Trade Name
- Epitomee EUDAMEDFDA UDI
- Generic Name
- Ingested gastric satiety device FDA UDI
- Device Name
- Epitomee capsule EUDAMEDEpitomee® is indicated to aid weight management in adults with excess weight or obesity. When taken with water, Epitomee® releases compartments filled with gel particles that form a triangular shape in the stomach. The particles absorb water, and the compartments swell. This helps one feel full sooner and eat less. The Epitomee® capsule's action is purely mechanical and does not involve any chemical activity. FDA UDI
- Model / Reference
- 6,6 EUDAMED2TAC- 56 EUDAMED6.6 FDA UDI
- Description
- Epitomee® is indicated to aid weight management in adults with excess weight or obesity. When taken with water, Epitomee® releases compartments filled with gel particles that form a triangular shape in the stomach. The particles absorb water, and the compartments swell. This helps one feel full sooner and eat less. The Epitomee® capsule's action is purely mechanical and does not involve any chemical activity. FDA UDI
Identifiers
- Catalog Number
- 2TAC-56 FDA UDI
- Primary DI / UDI-DI
- 27290017914019 EUDAMEDFDA UDI
- Basic UDI-DI
- 729001791400BU EUDAMED
- 510(k) Number
- K240544 FDA UDI
- FDA Product Code
- QFQ FDA UDI
- EMDN Code
- G030699 DEVICES FOR THE NON-SURGICAL TREATMENT OF OBESITY - OTHER EUDAMED
- GMDN Term
- Ingested gastric satiety device FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5982 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Epitomee by Epitomee Medical Ltd — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240544 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 729001791400BU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Epitomee Medical Ltd
- EUDAMED SRN
- IL-MF-000018148
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (3)
- EUDAMED 24bcc048-7f19-4785-811f-fb5ef2c547f8 61 fields · synced Jul 16, 2026
- FDA UDI eef2e650-2a7e-4f70-9b17-2d89272738ad 35 fields · synced May 26, 2026
- FDA 510(k) K240544 1 fields · synced May 18, 2026