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YUWELL Sleep Apnea Breathing Therapy Mask YN-03 (M)

by Suzhou Yuyue Medical Technology Co., Ltd.

Ref MN03002Model YN-01, YN-02, YN-03, YN-03T, YN-05, YN-06, YN-02A, YN-03A, YN-03TA , YN-03TH, YN-06H

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69221665YNM001QC Basic UDI-DI 06922166510558UDI-DIDate7 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06922166510558 UDI-DI Date15 Oct 2021ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Nasal Mask EUDAMED
YUWELL Sleep Apnea Breathing Therapy Mask GUDID
Generic Name
CPAP/BPAP nasal mask, reusable
Device Name
Sleep apnea breathing therapy mask
Model / Reference
YN-01 EUDAMED
YN-02 EUDAMED
YN-03 EUDAMED
YN-03T EUDAMED
YN-05 EUDAMED
YN-06 EUDAMED
YN-02A EUDAMED
YN-03A EUDAMED
YN-03TA EUDAMED
YN-03TH EUDAMED
YN-06H EUDAMED
MN03002 EUDAMED
YN-03 (M) GUDID
Primary DI / UDI-DI
06922166510558
Basic UDI-DI
69221665YNM001QC
FDA Product Code
BZD
EMDN Code
R0301010201, R0301010202
GMDN Term
CPAP/BPAP nasal mask, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5905
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No