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Seca

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

Ref Seca trace Q-tab

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number009336ECG-ECG-ElecSECAQ4 Basic UDI-DI 10009336010308UDI-DIDate16 Oct 2026RegisteredStatusActive

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  • Withdrawn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
Seca electrodes
Model / Reference
Seca trace Q-tab
Primary DI / UDI-DI
10009336010308
Basic UDI-DI
009336ECG-ECG-ElecSECAQ4
Unit of Use DI
00009336010301
EMDN Code
C020501 ECG electrodes
Device Class
Class I
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