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Manix

by Suretex Limited Thailand EUDAMED

Ref 400053

EMDN U99

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-03532281488309 Basic UDI-DIDate15 Oct 2021RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
MANIX Intimity
Model / Reference
400053
Primary DI / UDI-DI
03532281488309
Basic UDI-DI
B-03532281488309
EMDN Code
U99 Devices for urogenital system - other
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
TH-MF-000001364
Authorised representative
SXWell Belgium BE-AR-000001272

Other devices from Suretex Limited

See all devices from Suretex Limited →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 8db4e020-4baa-4275-99b5-0f723ee6272a 61 fields · synced 22 Oct 2026