RightLance Blood Lancing System

Multiple Use Blood Lancet For Single Patient Use Only

Beijing Ruicheng Medical Supplies Co., Ltd.

The following data is part of a premarket notification filed by Beijing Ruicheng Medical Supplies Co., Ltd. with the FDA for Rightlance Blood Lancing System.

Pre-market Notification Details

Device IDK222034
510k NumberK222034
Device Name:RightLance Blood Lancing System
ClassificationMultiple Use Blood Lancet For Single Patient Use Only
Applicant Beijing Ruicheng Medical Supplies Co., Ltd. No.13 Yanqi Ave, Yanqi Economic Development Zone, Huairou District Beijing,  CN 101400
ContactYuechao Li
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing,  CN 102401
Product CodeQRL  
CFR Regulation Number878.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-11
Decision Date2022-09-07

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