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Set SunChip 2

by Gamida Tech France EUDAMED

Ref 50_02_060Model 7109

EMDN Z1204021585

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number37003704SetSC2OPENYN Basic UDI-DIDate21 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Set SunChip 2
Model / Reference
7109, 50_02_060
Primary DI / UDI-DI
03700370400895
Basic UDI-DI
37003704SetSC2OPENYN
Direct Marketing DI
03700370400895
EMDN Code
Z1204021585 Multi-district oncological therapy instruments (excluding radiotherapy) - consumables
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000009097

Other devices from Gamida Tech

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • CMR Substance
  • Administering Medicine
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED b3eec106-f538-49a4-8945-47e05158249f 61 fields · synced 22 Oct 2026