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Indigo Carmine 1 % Non Sterile

by Derm Tech France EUDAMED

Active European Union

Ref J2F/810160/4Model INDIGO CARMINE 1 %, INDIGO CARMINE 1%

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-03701264500004 Basic UDI-DIDate21 Jul 2026RegisteredStatusActive
European UnionCE/MDD NumberB-03701264500004 Basic UDI-DIDate21 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Indigo Carmine 1 % Non Sterile
Indigo Carmine 1% Non Sterile
Model / Reference
INDIGO CARMINE 1 %, J2F/810160/4, INDIGO CARMINE 1%
Primary DI / UDI-DI
03701264500004
Basic UDI-DI
B-03701264500004, 37012645INDIGO_CARMINL5
Direct Marketing DI
03701264500004
EMDN Code
G030703 Markers for evaluation of gastrointestinal passage
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000017518

Other devices from Derm Tech France

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