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Nasal Pillows Mask

by Suzhou Yuyue Medical Technology Co., Ltd.

Ref MP01004Model YP-01, YP-06, YP-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 Number69221665YPM001R2 Basic UDI-DI 06922166510244UDI-DIDate10 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06922166510244 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  • Withdrawn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 Pillows 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
YP-01 EUDAMED
YP-06 EUDAMED
YP-06H EUDAMED
MP01004 EUDAMED
YP-01 (SML) GUDID
Primary DI / UDI-DI
06922166510244
Basic UDI-DI
69221665YPM001R2
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
YP-01, YP-06, YP-06H
MP01004
GUDID
YP-01 (SML)
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