Skip to content

CarmIndy

by S.A.L.F. S.p.A. Laboratorio Farmacologico Italy EUDAMED

Ref MICA4010, MICS4010

EMDN G030799

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberEPT 0477.MDR.22/4911.2 Date3 Mar 2025IssuedStatusActive expires 3 Aug 2027

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.22/4911.2 Reissued

    Quality management system EU MDR

    Notified body
    Notified body 0477
    Issued
    3 Mar 2025
    Expires
    3 Aug 2027

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
MICA4010, MICS4010
Primary DI / UDI-DI
08052742103985, 08052742102759, 08052742103558
Basic UDI-DI
805274210CaIndyMC
Unit of Use DI
18052742103982, 18052742102756, 18052742103555
EMDN Code
G030799 Gastrointestinal endoscopy, diagnostic devices - other
Device Class
Class IIa
Market of Registration
Italy
Germany

Manufacturer details

EUDAMED SRN
IT-MF-000010720

Other devices from S.A.L.F. S.p.A. Laboratorio Farmacologico

  • Eparina sodica S.A.L.F.

    Class III
  • SalineSlush

    Class IIa
  • MethyBlue

    Class IIa
  • Servator H

    Class III
  • Pancreas LOCK S.A.L.F.

    Class IIb
  • Servator C

    Class III

See all devices from S.A.L.F. S.p.A. Laboratorio Farmacologico →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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 (3)

  • EUDAMED 19a27232-cb6f-42e7-bc3a-cabf97131538 61 fields · synced 22 Oct 2026
  • EUDAMED 08052742102759|805274210CAINDYMC 61 fields · synced 17 May 2026
  • EUDAMED 08052742103558|805274210CAINDYMC 61 fields · synced 18 May 2026