Skip to content

Automatic External Defibrillator

by Ambulanc (Shenzhen) Tech. Co., Ltd. 8 variants

Ref i9Model i7、i7 Plus、i9、i9 Plus、LS1 Semi Automatic、 LS1 Pro Semi Automatic、 LS1 Fully Automatic、 LS1 Pro Fully Automatic

Active European Union

CE MDR

Valid until

14 Jul 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

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 Number69706581400199X Basic UDI-DI 06970658141339UDI-DIDate22 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 779600 Active

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    15 Jul 2026
    Expires
    14 Jul 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
i7、i7 Plus、i9、i9 Plus、LS1 Semi Automatic、 LS1 Pro Semi Automatic、 LS1 Fully Automatic、 LS1 Pro Fully Automatic, i9
Primary DI / UDI-DI
06970658141339
Basic UDI-DI
69706581400199X
Direct Marketing DI
06970658141339
EMDN Code
Z12030501 Semi-automatic defibrillators
Device Class
Class III
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000010435
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Ambulanc(Shenzhen)Tech.Co., Ltd.

See all devices from Ambulanc(Shenzhen)Tech.Co., Ltd. →

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No