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Anaesthesia Mask

by Ningbo Shengyurui Medical Appliances Co., Ltd.

Ref A0811, A0812Model AnesEasy and AnesFlex

Active European Union

CE MDR

Valid until

28 Nov 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCN24/00007564 Date5 Oct 2026IssuedStatusActive expires 28 Nov 2029

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN24/00007564 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    5 Oct 2026
    Expires
    28 Nov 2029
    Reason
    Change approved

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Anesthesia Mask
Model / Reference
AnesEasy and AnesFlex, A0811, A0812
Primary DI / UDI-DI
06945099392985, 06945099392992
Basic UDI-DI
69450993AMK001LZ
Direct Marketing DI
06945099392985
06945099392992
EMDN Code
R03010101 Anaesthetic face masks
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000026643
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Anaesthesia face mask, single-use

Other devices from Ningbo Shengyurui Medical Appliances Co., Ltd.

See all devices from Ningbo Shengyurui Medical Appliances Co., Ltd. →

Properties

Other properties (13)

  • Sterile: 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