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Microscopic Image Scanner

by Shanghai Howsome Biotechnology co., Ltd. China EUDAMED

Ref Micro SCANNER Alpha Model Micro SCANNER Alpha、Micro SCANNER Beta、Micro SCANNER Gamma、Micro SCANNER Delta、Micro SCANNER Epsilon、Micro SCANNER Plus、Micro SCANNER Rainbow Ultra、Micro SCANNER Rainbow Mini、etc

EMDN W0202050301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number698000638ImageScannerMY Basic UDI-DIDate16 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Microscopic Image Scanner
Model / Reference
Micro SCANNER Alpha、Micro SCANNER Beta、Micro SCANNER Gamma、Micro SCANNER Delta、Micro SCANNER Epsilon、Micro SCANNER Plus、Micro SCANNER Rainbow Ultra、Micro SCANNER Rainbow Mini、etc, Micro SCANNER Alpha
Primary DI / UDI-DI
06980006380013
Basic UDI-DI
698000638ImageScannerMY
EMDN Code
W0202050301 Electron microscopes
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000053315
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shanghai Howsome Biotechnology co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 342b7457-5da2-4f50-a0cc-536d2d94c414 61 fields · synced 22 Oct 2026