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FotoSan 630 Agent HIGH

by CMS Dental Denmark EUDAMED

Ref 215525Model Photosensitizers EMDN Q0199

Regulatory status

as of 25 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  • Withdrawn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 · synced 25 Oct 2026

Device Name
QROXB2 Endo
Model / Reference
Photosensitizers, 215525
Primary DI / UDI-DI
05713223001420
Basic UDI-DI
5713223SEN1Z6
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 & raw data

Show properties, registry sources and raw records
  • Reprocessed
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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 (1)

  • EUDAMED 91c25e80-79f2-4678-a40d-7049f02eea3c 61 fields · synced 25 Oct 2026