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Hybrid Microscope Software

by X-ZELL Biotech Pte. Ltd. Singapore EUDAMED

Ref XZ1027 EMDN V92

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++G580XZELLHybrScopeAFS Basic UDI-DIDate22 Dec 2023RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
Hybrid Microscope
Model / Reference
XZ1027
Primary DI / UDI-DI
++G580XZELLHybrScopeAFS1
Basic UDI-DI
++G580XZELLHybrScopeAFS
Direct Marketing DI
++G580XZELLHybrScopeAFS1
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
SG-MF-000039227
Authorised representative
X-ZELL Biotech GmbH DE-AR-000039132

Other devices from X-ZELL Biotech Pte. Ltd.

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED e6ae5e4c-ce8c-403b-9ac4-39033e948ac1 61 fields · synced 22 Oct 2026