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orthoS8

by SinfoMed Gesellschaft für Präventions-, Diagnose- und Rehasysteme mbH 4 variants

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

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 Number426251675EMG014J Basic UDI-DI 04262516750039UDI-DIDate7 Jul 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  • Withdrawn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

Model / Reference
orthoS8 (2-Channel), orthoS8 (4-Channel), orthoS8 (6-Channel), orthoS8 (8-Channel), 3701-2
Primary DI / UDI-DI
04262516750039
Basic UDI-DI
426251675EMG014J
EMDN Code
Z12100701 EMG telemetry systems
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000048702

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

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