Shandong Caremed Medical Products Co., Ltd.

Registered establishment in Heze, Shandong, China. 6 device types, 1 clearance.

Registry build 21.09.26

Shandong Caremed Medical Products Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Needle, Dental, Syringe, Piston and 4 other device types. Its earliest product listing with the FDA dates from 2016.

6device types registered with the FDA
1510(k) clearance

Registration

FDA registration record for Shandong Caremed Medical Products Co., Ltd.
Registered name SHANDONG CAREMED MEDICAL PRODUCTS CO.,LTD.
Status Registered
Registration expires 2026
Registration number 3012461127
FEI number 3012461127
Establishment type Manufacturer, Exporter

Chinese Registration

Chinese company register details for Shandong Caremed Medical Products Co., Ltd.
Chinese legal name 山东科锐医疗用品有限公司
Source Baidu Baike

Location

Address of Shandong Caremed Medical Products Co., Ltd.
City Heze
Province Shandong
Address YanTai Industrial Park, Ding Tao Country
Postal code 274100
Country China

What It Makes

Device types Shandong Caremed Medical Products Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Needle, Dental Class 1 Needle, Dental 2017 56
Needle, Hypodermic, Single Lumen Class 2 Needle, hypodermic, single lumen 2016 71
Set, Administration, Intravascular Class 2 Set, administration, intravascular 2017 49
Syringe, Antistick Class 2 Insulin Syringe, piston 2017 39
Syringe, Irrigating (Dental) Class 1 Syringe, irrigating (dental) 2017 22
Syringe, Piston Class 2 Syringe, piston, Insulin Syringe, piston 2016 60

Clearances

1 clearance names Shandong Caremed Medical Products Co., Ltd. as applicant. 5 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Shandong Caremed Medical Products Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K152824 2016-03-07 FMI Traditional This company
K152808 2016-03-25 MEG Traditional U&U Medical Technology Co., Ltd.
K151151 2015-09-24 FPA Traditional U&U Medical Technology Co., Ltd.
K142765 2015-08-11 FMI Traditional Thinkmed Medical Technology Co., Ltd.
K132553 2014-02-27 FMF Traditional U&U Medical Technology Co., Ltd.
K132552 2013-11-13 FMI Traditional U&U Medical Technology Co., Ltd.

From the Company

Published by the company on its own website, not by the FDA.

Information published by Shandong Caremed Medical Products Co., Ltd.
Main products hypodermic needles, syringes, medical equipment accessories
Certifications FDA registered
Export markets Global

Nearby Manufacturers

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