Skip to content

FotoSan Blue Agent GEL, 0, 5ml

by CMS Dental EUDAMED

Active European Union

Ref 228211, 100412Model Photosensitizers, Cure and Photosensitizer Lights

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5713223SEN1Z6 Basic UDI-DIDate26 Apr 2022RegisteredStatusActive

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  • Withdrawn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

Trade Name
FotoSan Blue Agent GEL, 0,5ml
FotoSan Blue
Device Name
QROXB2 Endo
Model / Reference
Photosensitizers, 228211, Cure and Photosensitizer Lights, 100412
Primary DI / UDI-DI
05713223001888, 05713223000232
Basic UDI-DI
5713223SEN1Z6, 5713223CPL1X7
EMDN Code
Q0199 Odontology devices - other
Device Class
Class I
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000020260

Other devices from CMS Dental

See all devices from CMS Dental →

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