Data / Medical devices / Microtome, Rotary
Microtome, Rotary (IDO): 21 FDA-registered makers in 8 countries
21 establishments in 8 countries are registered with the FDA to make Microtome, Rotary (product code IDO, Class 1, 21 CFR 864.3010). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on January 5, 1987, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IDO
- Device class
- 1
- Regulation
- 864.3010
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| China | 6 |
| India | 4 |
| United States | 3 |
| Germany | 3 |
| Italy | 2 |
| Spain | 1 |
| Netherlands | 1 |
| United Kingdom | 1 |
Makers of Microtome, Rotary
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 | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Clarapath, Inc. | Hawthorne, NY, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dakewe(shenzhen) Medical Equipment Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diapath S.P.A. | Martinengo Bergamo, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Especialidades Medicas Myr SL | Llorenc del Pendes Tarragona, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epredia Laboratory Products Manufacturing (Shanghai) Co., Ltd | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Four E's Scientific Co., Ltd. | GUANGZHOU Guangdong, China | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leica Biosystems Nussloch GMBH | NUSSLOCH Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai, China | Contract manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medimeas Instruments | Ambala Cantt Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medite Medical GMBH | Burgdorf Lower Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Milestone S.P.A. | Sorisole Bergamo, Italy | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Morphle Labs Inc | Lewes, DE, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Narang Medical, Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pathnsitu Biotechnologies Pvt Ltd | HYDERABAD Telangana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RWD Life Science Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sakura Finetek Europe B.V. | Alphen aan den Rijn Zuid-Holland, Netherlands | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sakura Finetek U.s.a., Inc. | Torrance, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandon Diagnostics Limited | RUNCORN Cheshire East, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sipcon Technologies Private Limited | Ambala Haryana, India | Manufacturer | 0 | 0 | 0 | 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 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Gene Science Co., Ltd | shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 5, 1987. 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.