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Eswell

by Simonsen & Weel A/S Denmark EUDAMED

Ref 248019Model Pad semi circular shaped 500, bariatric EMDN V080399

Overview

The ESWELL device is a revolutionary medical device used in bariatric surgery, offering a safe and effective solution for individuals seeking weight loss. By simulating the natural mechanical stress environment of the human body, it enables surgeons to perform complex procedures with greater precision and reduced recovery time.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5712855ESWELL3B Basic UDI-DIDate16 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Pad semi circular shaped 500, bariatric, 248019
Primary DI / UDI-DI
05712855001389
Basic UDI-DI
5712855ESWELL3B
EMDN Code
V080399 Medical cushions - other
Device Class
Class I
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000035987

Other devices from Simonsen & Weel A/S

See all devices from Simonsen & Weel A/S →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED d104a845-1d9e-4f67-9a82-ad8182d5277a 61 fields · synced 22 Oct 2026