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SurgiMedia - Light Manager

by Isis - Intelligent Surgical Instruments & Systems

Ref IS2002Model Application logicielle de pilotage d'éclairage opératoire

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3770022348IS5004RC Basic UDI-DIDate25 Nov 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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
SurgiMedia - Light Manager
Model / Reference
Application logicielle de pilotage d'éclairage opératoire, IS2002
Primary DI / UDI-DI
03770022348530
Basic UDI-DI
3770022348IS5004RC
Direct Marketing DI
03770022348530
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000009585

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