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Full Face Mask

by Suzhou Yuyue Medical Technology Co., Ltd. EUDAMEDGUDID

Active European Union

Ref MF01003Model YF-01, YF-02, YF-03, YF-05, YF-06, YF-RT01, YF-RT02, YF-RT03, YF-01A, YF-02A, YF-02X

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69221665YFM001ML Basic UDI-DIDate7 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06922166510596 UDI-DIDate15 Oct 2021ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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
MF01003 EUDAMED
YF-01 (L) GUDID
Primary DI / UDI-DI
06922166510596
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
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

Manufacturer details

EUDAMED SRN
CN-MF-000015854
Authorised representative
Metrax GmbH DE-AR-000005481

Other devices from Suzhou Yuyue Medical Technology Co., Ltd.

See all devices from Suzhou Yuyue Medical Technology Co., Ltd. →

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