Data / Medical devices / Microtome, Cryostat

Microtome, Cryostat (IDP): 17 FDA-registered makers in 5 countries

Name: FDA-registered makers of Microtome, Cryostat
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

17 establishments in 5 countries are registered with the FDA to make Microtome, Cryostat (product code IDP, Class 1, 21 CFR 864.3010). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on August 29, 1988, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: IDP
Device class: 1
Regulation: 864.3010
Medical specialty: Pathology

Makers by country

Country	Makers
China	8
India	4
Germany	3
United States	1
United Kingdom	1

Makers of Microtome, Cryostat

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	Recall events	Source
Dakewe(shenzhen) Medical Equipment Co., Ltd	Shenzhen Guangdong, China	Manufacturer	0	api.fda.gov
Epredia Laboratory Products Manufacturing (Shanghai) Co., Ltd	Shanghai, China	Contract manufacturer	0	api.fda.gov
Infitek Co., Ltd.	Shanghai, China	Manufacturer	0	api.fda.gov
Labpeak Co.,ltd	Jinan Shandong, China	Exporter to the US, Manufacturer	0	api.fda.gov
Leica Biosystems Nussloch GMBH	NUSSLOCH Baden-Wurttemberg, Germany	Manufacturer	2	api.fda.gov
Leica Instruments (Shanghai) Co., Ltd.	Shanghai, China	Specification developer	0	api.fda.gov
Mark Enterprises	Nashik Maharashtra, India	Manufacturer	0	api.fda.gov
Medimeas Instruments	Ambala Cantt Haryana, India	Manufacturer	0	api.fda.gov
Medite Medical GMBH	Burgdorf Lower Saxony, Germany	Manufacturer	0	api.fda.gov
RWD Life Science Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0	api.fda.gov
Sakura Finetek U.s.a., Inc.	Torrance, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Scitek Global Co.,ltd	Jinan Shandong, China	Exporter to the US, Manufacturer	0	api.fda.gov
Shandon Diagnostics Limited	RUNCORN Cheshire East, United Kingdom	Manufacturer	0	api.fda.gov
Shanghai Youding International Trade Co., Ltd.	Shanghai, China	Manufacturer	0	api.fda.gov
Sipcon Technologies Private Limited	Ambala Haryana, India	Manufacturer	0	api.fda.gov
Slee Medical GMBH	Nieder-Olm Rhineland-Palatinate, Germany	Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer	0	api.fda.gov
Uni Meditrek Private Limited	Ghaziabad Uttar Pradesh, India	Manufacturer	0	api.fda.gov

Updated August 29, 1988. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.