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Sc-01

by NEURIVE Co., Ltd EUDAMED

Active European Union

Ref manyModel SC-01

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880025969SCL01F6 Basic UDI-DIDate8 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
SoriCLEAR
Model / Reference
SC-01, many
Primary DI / UDI-DI
08800259690005
Basic UDI-DI
880025969SCL01F6
Direct Marketing DI
08800259690005
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000050906
Authorised representative
Grambly GmbH DE-AR-000041968

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