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CPAP/BiPAP Headgear

by Ruimai Medical Technology (Dongguan) Co., Ltd.

Ref 06976304590117Model N20 Headgear,N20 Headgear 052,F20 Headgear,F20Pro Headgear,P10 Headgear,wisp Frame,wisp Headgear,Universal Headgear W062,DreamWear Headgear 074,Universal Headgear W067,Universal Headgear 0306,Universal Headgear 061,N30i Headgear,Nuance Pro Headgear

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697630459001KT Basic UDI-DI 06976304590117UDI-DIDate12 Aug 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
CPAP/BiPAP Headgear
Model / Reference
N20 Headgear, N20 Headgear 052, F20 Headgear, F20Pro Headgear, P10 Headgear, wisp Frame, wisp Headgear, Universal Headgear W062, DreamWear Headgear 074, Universal Headgear W067, Universal Headgear 0306, Universal Headgear 061, N30i Headgear, Nuance Pro Headgear, 06976304590117
Primary DI / UDI-DI
06976304590117
Basic UDI-DI
697630459001KT
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000049086
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Related devices

Category: Device sterilization/disinfection container, reusable

Properties

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