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YUWELL Sleep Apnea Breathing Therapy Mask YF-02 (M)

by Suzhou Yuyue Medical Technology Co., Ltd.

Ref MF02002Model YF-01, YF-02, YF-03, YF-05, YF-06, YF-RT01, YF-RT02, YF-RT03, YF-01A, YF-02A, YF-02X

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 Number69221665YFM001ML Basic UDI-DI 06922166510619UDI-DIDate7 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06922166510619 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  • Withdrawn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
Full Face Mask EUDAMED
YUWELL Sleep Apnea Breathing Therapy Mask GUDID
Generic Name
CPAP/BPAP face mask, reusable
Device Name
Sleep Apnea Breathing Therapy Mask
Model / Reference
YF-01 EUDAMED
YF-02 EUDAMED
YF-03 EUDAMED
YF-05 EUDAMED
YF-06 EUDAMED
YF-RT01 EUDAMED
YF-RT02 EUDAMED
YF-RT03 EUDAMED
YF-01A EUDAMED
YF-02A EUDAMED
YF-02X EUDAMED
MF02002 EUDAMED
YF-02 (M) GUDID
Primary DI / UDI-DI
06922166510619
Basic UDI-DI
69221665YFM001ML
FDA Product Code
BZD
EMDN Code
R0301010201, R0301010202
GMDN Term
CPAP/BPAP face 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