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12-Lead Analysis Optional Software

by Fukuda Denshi Co., Ltd. 4 variants

Ref DS-8200-12LA

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 Number4538612020019P Basic UDI-DI 04538612911163UDI-DIDate20 Apr 2023RegisteredStatusActive

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  • Withdrawn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
Accessories for Measuring and Monitoring Device for Vital Signs
Model / Reference
DS-8200-12LA
Primary DI / UDI-DI
04538612911163
Basic UDI-DI
4538612020019P
EMDN Code
Z1203020282 Multi-parameter monitors - software accessories
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
JP-MF-000008253
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Fukuda Denshi Co., Ltd.

See all devices from Fukuda Denshi 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