Kolo Medical (Suzhou) Co., Ltd.

Brand owner, China. 2 products catalogued, 1 clearance.

Registry build 21.09.26

Kolo Medical (Suzhou) Co., Ltd. holds an FDA establishment registration in China. Its registration names no device type; it is in this index because it catalogues devices under its own name. 2 of its products are catalogued under its own name.

2products catalogued under its own name
1510(k) clearance

Registration

FDA registration record for Kolo Medical (Suzhou) Co., Ltd.
Status Not current
DUNS 550397899

Location

Address of Kolo Medical (Suzhou) Co., Ltd.
Country China

Own-Brand Listings

Devices catalogued by Kolo Medical (Suzhou) Co., Ltd.
Product Code Catalogue numbers
Kolo IYN 6
Kolo ITX 4

Clearances

510(k) clearances naming Kolo Medical (Suzhou) Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K221568 2022-09-12 IYN Traditional This company

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer