Data / Medical devices / Device For Sealing Microsections
Device For Sealing Microsections (KIM): 10 FDA-registered makers in 6 countries
10 establishments in 6 countries are registered with the FDA to make Device For Sealing Microsections (product code KIM, Class 1, 21 CFR 864.3400). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on April 18, 1978, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KIM
- Device class
- 1
- Regulation
- 864.3400
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| Germany | 3 |
| China | 2 |
| India | 2 |
| Indonesia | 1 |
| Japan | 1 |
| United Kingdom | 1 |
Makers of Device For Sealing Microsections
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 |
|---|---|---|---|---|---|---|---|---|
| Dakewe(shenzhen) Medical Equipment Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Island Polymer Industries-Gmbh | BITTERFELD-WOLFEN Saxony-Anhalt, Germany | Manufacturer | 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 | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medimeas Instruments | Ambala Cantt Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT PHC Indonesia | Cikarang Barat Bekasi Jawa Barat, Indonesia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sakura Seiki Co., Ltd. | CHIKUMA-CITY Nagano, Japan | Manufacturer | 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 | Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 18, 1978. 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.