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Nissha Medical Technologies

by Graphic Controls Acquisition Corp d.b.a Nissha Medical Technologies 85 variants

Ref T100AC-MINDRAY

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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 Number009336Defib-Elec6F Basic UDI-DI 50009336010795UDI-DIDate13 Sep 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
HeartSync
Model / Reference
T100AC-MINDRAY
Primary DI / UDI-DI
50009336010795
Basic UDI-DI
009336Defib-Elec6F
Unit of Use DI
00009336010790
EMDN Code
C020401 External cardioversion defibrillator electrode pads
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
US-MF-000012773
Authorised representative
NISSHA MEDICAL TECHNOLOGIES SAS FR-AR-000009795

Other devices from Graphic Controls Acquisition Corp d.b.a Nissha Medical Technologies

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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