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Hematology / histology / cytology instrumentsHistology / cytologyVarious processing instruments for hystology / cytology

Cryostat microtomes

EMDN code W0202059003

8 manufacturers, 14 models including 14 on the market, 5 countries

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Manufacturers registered in Europe (EUDAMED) 8
  • On the market
  • No longer marketed
  • 93/42 Former directive, not yet certified under the MDR
  • Click a manufacturer to see its full range, a model to open its EUDAMED record.
ManufacturerCountryRegistered modelsClassContact
Leicabiosystems FDA Germany A IVDR Website support.de@LeicaBiosystems.com EUDAMED record Report an error
Shandon Diagnostics FDA EU representative : Epredia Netherlands B.V. (Netherlands) United Kingdom (ex Northern Ireland) A IVDR EUDAMED record Report an error
Dakewe FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR Website EUDAMED record Report an error
Medite FDA Germany A IVDR Website EUDAMED record Report an error
Milestone FDA Italy A IVDR Website marketing@milestonemedsrl.com EUDAMED record Report an error
Sakura Finetek USA EU representative : Sakura Finetek Europe B.V. (Netherlands) United States A IVDR PRRC@sakuraus.com EUDAMED record Report an error
Shenyang Kingpel Biotech EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Xiaogan Kuohai Medical Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 14

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

ManufacturerCountryBrandsFDA clearance
Dakewe (Shenzhen) Medical Equipment Co., Ltd. China CT520 Cryostat Microtome CT620 Cryostat Microtome 6250 Cryostat Microtome registered
Epredia Holdings Ltd. United States – registered
Infitek Co., Ltd. Present in Europe in other categories China – registered
Labpeak Co.,Ltd China – registered
Leica Biosystems, division of Leica Microsystems, Inc. United States – registered
MEDIMEAS INSTRUMENTS India – registered
Mark Enterprises India – registered
RWD Life Science Co., Ltd. Present in Europe in other categories China – registered
SHANGHAI YOUDING INTERNATIONAL TRADE CO., LTD. China – registered
SLEE medical GmbH Present in Europe in other categories Germany – registered
Sakura Global Holding Company United States – registered
Scitek Global Co.,Ltd China – registered
Sipcon Technologies Private Limited India – registered
UNI MEDITREK PRIVATE LIMITED India – registered

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