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Disposable Anesthetic Masks XY-MZ-A-2

by Ningbo Xinwell Medical Technology Co., Ltd.

Ref AMR53020HModel A

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 Number697452906AF3 Basic UDI-DI 06942067998866UDI-DIDate27 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06942067998866 UDI-DI Date22 Feb 2025ListedStatusListed 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  • Withdrawn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
Disposable Anesthetic Masks
Generic Name
Anaesthesia face mask, single-use
Model / Reference
A EUDAMED
AMR53020H EUDAMED
XY-MZ-A-2 GUDID
Primary DI / UDI-DI
06942067998866 EUDAMED
06974529067124 GUDID
Basic UDI-DI
697452906AF3
FDA Product Code
BSJ
EMDN Code
R03010101 Anaesthetic face masks
GMDN Term
Anaesthesia face mask, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5550
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 4 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
A
AMR53020H
GUDID
XY-MZ-A-2
Primary DI / UDI-DIEUDAMED
06942067998866
GUDID
06974529067124
Device ClassEUDAMED
Class IIa
GUDID
Class I
SterileEUDAMED
Yes
GUDID
No

Related devices

Category: Anaesthesia face mask, single-use

Other devices from Ningbo Xinwell Medical Technology Co., Ltd.

See all devices from Ningbo Xinwell Medical Technology Co., Ltd. →

Properties

  • Sterile YesEUDAMEDNoGUDID
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Serial Number: No