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Motic

by Motic China Group Co., Ltd. China EUDAMED

Ref PX55 FS8Model AE31E AE2000 PX43 BIO PX55FS8 PX55 BIO

EMDN W0202050301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697396716IBMicroscopeM2 Basic UDI-DIDate13 Jul 2025RegisteredStatusActive

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
Inverted Biological Microscope
Model / Reference
AE31E AE2000 PX43 BIO PX55FS8 PX55 BIO, PX55 FS8
Primary DI / UDI-DI
06973967160732
Basic UDI-DI
697396716IBMicroscopeM2
Direct Marketing DI
06973967160732
EMDN Code
W0202050301 Electron microscopes
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000033671
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Motic China Group Co., Ltd.

See all devices from Motic China Group Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
  • New Device
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED 3729de2d-02fe-41a0-b51c-e8b35606194e 61 fields · synced 22 Oct 2026