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Data / Medical devices / China / Ranir Changshu Oral Care CO., Ltd

Ranir Changshu Oral Care CO., Ltd: FDA-registered device maker in Changshu Jiangsu, China, 1 510(k) clearance

Ranir Changshu Oral Care CO., Ltd is registered with the FDA (registration 3007336881) in Changshu Jiangsu, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 8, 2009. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3007336881
Address
Building 2, Export Processing Zone Wangwan North Road, CEDZ, Changshu Jiangsu, China, 215513
Owner or operator
RANIR LLC (1825660)
Roles
Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
July 2, 1992
Registered through
2026
Brand names listed
1G, 3G, Advance Clean, EasyFlex, Essential Clean USB, Grind-No-More, Infinity, Kids and more

Devices it lists

DeviceProduct codeClassRoleSource
Floss, DentalJES1Exporter to the US, Manufactureraccessdata.fda.gov
Mouthguard, Over-The-CounterOBRUManufactureraccessdata.fda.gov
Toothbrush, ManualEFW1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Toothbrush, PoweredJEQ1Repackager or relabeleraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 8, 2009K091175GRIND NO MORE VERSION 2 AND 3OBRSubstantially EquivalentRanir, LLCaccessdata.fda.gov

Compare with other makers

Updated May 8, 2009. 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.