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Embedding Cassette

by Shanghai THAN Medical Technology Co., Ltd 10 variants

Ref M6001Model M8001, M8002, M8003, M8004, M8005, M6001,M6002, M6003, M6004, M6005,M8001-1, M8001-2, M8002-1, M8002-2, M8003-1, M8003-2, M6001-1, M6001-2, M6002-1, M6002-2, M6003-1, M6003-2, MC01, MC02, MC01-1, MC01-2, MC02-1, MC02-2, BC01, etc.

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697762446CASSETTEL6 Basic UDI-DI 06977624461859UDI-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  • Withdrawn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
Embedding Cassette
Model / Reference
M8001, M8002, M8003, M8004, M8005, M6001, M6002, M6003, M6004, M6005, M8001-1, M8001-2, M8002-1, M8002-2, M8003-1, M8003-2, M6001-1, M6001-2, M6002-1, M6002-2, M6003-1, M6003-2, MC01, MC02, MC01-1, MC01-2, MC02-1, MC02-2, BC01, etc.
Primary DI / UDI-DI
06977624461859
Basic UDI-DI
697762446CASSETTEL6
EMDN Code
W05030501 Inclusion devices, cassettes
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