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RefluxStop Deployment tool

by Implantica CE Reflux Ltd. Malta EUDAMED

Ref RS-300

EMDN P058001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5350646RS300SX Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
RS-300
Primary DI / UDI-DI
05350646999912
Basic UDI-DI
5350646RS300SX
EMDN Code
P058001 Oesophageal and gastrointestinal prostheses positioning devices
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
MT-MF-000002866

Other devices from Implantica CE Reflux, Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (12)
  • Sterile: No
  • Implantable: 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 38773bdb-a706-489b-b9a3-9a3b5e3de266 61 fields · synced 22 Oct 2026