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Sleep Apnoea Therapy Devices

by Micomme Medical Technology Development Co., Ltd. China EUDAMED

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 EMDN Q03010299

Regulatory status

as of 25 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  • Withdrawn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: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

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
06959352702244
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 06959352702244|69593527RUYISERIESKP 61 fields · synced 25 Oct 2026