Epitomee

Primary DI
27290017914019
Brand
Epitomee
Company
EPITOMEE MEDICAL LTD
Model
6.6
Catalog number
2TAC-56
Device 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.
Published
2025-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QFQIngested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFQIngested, Transient, Space Occupying Device For Weight Management And/Or Weight LossGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240544000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240544000EpitomeeEpitomee Medical , Ltd.2024-09-13QFQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27290017914019PrimaryGS10
07290017914015Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2729001791401927290017914019
07290017914015072900179140157290017914015

GMDN Terms#

Term, Definition table
TermDefinition
Ingested gastric satiety deviceAn orally-administered device intended to facilitate weight loss and treat obesity through appetite control. It is designed to be swallowed before meals to form a viscous gel in the stomach and/or small intestine to increase distention, creating the sensation of fullness and causing the user to eat less. It may additionally slow down intestinal glucose absorption to improve glycaemic control. It typically includes natural or modified fibre which expands after absorbing water; it is available in tablet, capsule, and powder sachet forms. This is a single-use device.

Regulatory Flags#

DUNS number
514600985
Device count
56
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
27290017914026Epitomee6.62TAC-142025-04-22
07290017914015Epitomee6.62TAC-562025-04-22
07290017914022Epitomee6.62TAC-142025-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08055162880078Plenity®GELESIS SRLQFQ2026-01-14
08055162880009Plenity®GELESIS SRLQFQ2026-01-14
27290017914026EpitomeeEPITOMEE MEDICAL LTDQFQ2025-04-22
07290017914015EpitomeeEPITOMEE MEDICAL LTDQFQ2025-04-22
07290017914022EpitomeeEPITOMEE MEDICAL LTDQFQ2025-04-22
00860517002665Plenity®GELESIS, INC.QFQ2021-09-01
00860517002672Plenity®GELESIS, INC.QFQ2021-09-01
20860517002638Plenity®GELESIS, INC.QFQ2020-12-09
10860517002631Plenity™ GELESIS, INC.QFQ2020-05-06
00860517002634Plenity™ GELESIS, INC.QFQ2020-05-06
00860517002603Plenity™ GELESIS, INC.QFQ2020-03-09
00860517002627Plenity™ GELESIS, INC.QFQ2020-03-09