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Microscope Slides

by Shanghai THAN Medical Technology Co., Ltd 13 variants

Ref B8001-1Model B8001,B8001-1, B8001-2, B8002, B8002-1, B8002-2, B6001,B6002, B6001-1, B6001-2, B6002-1, B6002-2, ET01,ET01-1, ET01-2, ET02, ET02-1, ET02-2, MS01,MS01-1, MS01-2, MS02, MS02-1, MS02-2, CS01, CS01-1, CS01-2, CS02, CS02-1, CS02-2

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697762446SLIDESZ7 Basic UDI-DI 06977624461514UDI-DIDate26 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Microscope Slides
Model / Reference
B8001, B8001-1, B8001-2, B8002, B8002-1, B8002-2, B6001, B6002, B6001-1, B6001-2, B6002-1, B6002-2, ET01, ET01-1, ET01-2, ET02, ET02-1, ET02-2, MS01, MS01-1, MS01-2, MS02, MS02-1, MS02-2, CS01, CS01-1, CS01-2, CS02, CS02-1, CS02-2
Primary DI / UDI-DI
06977624461514
Basic UDI-DI
697762446SLIDESZ7
EMDN Code
W0503900201 Microscope slides
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000042882
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

  • Professional Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No