Skip to content

Dct

by Zhejiang Baite Medical Appliances Co., Ltd. EUDAMED

Active European Union

Ref H7 1116

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06974269382396 Basic UDI-DIDate10 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

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.

Specification

EUDAMED

Device Name
Oxygen mask
Model / Reference
H7 1116
Primary DI / UDI-DI
06974269382396
Basic UDI-DI
B-06974269382396
EMDN Code
R03010201 Air/oxygen masks
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000021983
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Zhejiang Baite Medical Appliances Co., Ltd.

See all devices from Zhejiang Baite Medical Appliances Co., Ltd. →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No