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orthoS8

by SinfoMed Gesellschaft für Präventions-, Diagnose- und Rehasysteme mbH Germany EUDAMED

Ref 3701-6Model orthoS8 (2-Channel), orthoS8 (4-Channel), orthoS8 (6-Channel), orthoS8 (8-Channel)

EMDN Z12100701

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426251675EMG014J Basic UDI-DIDate7 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
orthoS8 (2-Channel), orthoS8 (4-Channel), orthoS8 (6-Channel), orthoS8 (8-Channel), 3701-6
Primary DI / UDI-DI
04262516750053
Basic UDI-DI
426251675EMG014J
EMDN Code
Z12100701 EMG telemetry systems
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000048702

Other devices from SinfoMed Gesellschaft für Präventions-, Diagnose- und Rehasysteme mbH

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 2d57ac59-f6de-435b-97dd-12f42d8659bd 61 fields · synced 22 Oct 2026