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Tianjin Rilifine Medical Device Co.,ltd: FDA-registered device maker in Tianjin, China, 2 510(k) clearances

Name: Tianjin Rilifine Medical Device Co.,ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Tianjin Rilifine Medical Device Co.,ltd is registered with the FDA (registration 3021314645) in Tianjin, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 21, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3021314645
Address: No 32, Jingguan Road, Yixingbu, Beichen District, Tianjin, China, 300402
Owner or operator: Tianjin Rilifine Medical Device Co.,Ltd (10083487)
Roles: Manufacturer
First device listed: November 23, 2021
Registered through: 2026
Brand names listed: Disposable Sterile Lancet; AHG-IIA safety lancets;, Disposable Sterile Lancet; Lancing device; AHG-IA twist lancets; AHG-IIIA lancing device;, Lancet,Blood lancets,Lancing device,Lancet device,Safety lancet,Twist lancet, Specification: 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G, 32G, 33G, 34G

Devices it lists

Device	Product code	Class	Role	Source
Multiple Use Blood Lancet For Single Patient Use Only	QRL	2	Manufacturer	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Manufacturer	accessdata.fda.gov
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	QRK	2	Manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 21, 2022	K222246	Disposable Sterile Lancet	QRL	Substantially Equivalent	Tianjin Rilifine Medical Device Co., Ltd.	accessdata.fda.gov
November 15, 2022	K222055	Disposable Sterile Lancet	FMK	Substantially Equivalent	Tianjin Rilifine Medical Device Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 21, 2022. 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.