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Cynapse IONM System

by Shanghai NCC Electronic Corp., Ltd. 4 variants

Ref IONM-HSModel IONM-HDPro, IONM-HD, IONM-HSPro, IONM-HS

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 linked in EUDAMED

A group certificate may exist

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 Number697595664CE03Q7 Basic UDI-DI 06975956640409UDI-DIDate16 Jul 2026RegisteredStatusActive

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

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
: Intraoperative Neurophysiological Monitoring (IONM) System
Model / Reference
IONM-HDPro, IONM-HD, IONM-HSPro, IONM-HS
Primary DI / UDI-DI
06975956640409
Basic UDI-DI
697595664CE03Q7
Direct Marketing DI
06975956640409
EMDN Code
Z121002 Nervous system monitoring systems
Device Class
Class IIb
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000037569
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Shanghai NCC Electronic Corp., 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