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Sleep Apnoea Therapy Devices

by Micomme Medical Technology Development Co., Ltd. EUDAMED

Active European Union

Ref /Model C1, C2, C3, C5, B1, B5, S1, T1, T2, T3, T5, P1, ResElite C20, ResElite C20A, ResElite C20S, ResElite C20P, ResElite B25A, ResElite B25P, ResElite T25, ResElite T25H, ResElite T30S, ResElite T30P

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69593527RUYISERIESKP Basic UDI-DIDate11 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
C1, C2, C3, C5, B1, B5, S1, T1, T2, T3, T5, P1, ResElite C20, ResElite C20A, ResElite C20S, ResElite C20P, ResElite B25A, ResElite B25P, ResElite T25, ResElite T25H, ResElite T30S, ResElite T30P, /
Primary DI / UDI-DI
06959352701018
Basic UDI-DI
69593527RUYISERIESKP
EMDN Code
Q03010299 Antisnoring and obstructive sleep apnoea devices - other
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000008694
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Micomme Medical Technology Development Co., Ltd.

See all devices from Micomme Medical Technology Development Co., Ltd. →

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No