Data / Medical devices / Netherlands / Masena Invest, BV

Masena Invest, BV: FDA-registered device maker in Dordrecht Zuid-Holland, Netherlands, 17 510(k) clearances

Name: Masena Invest, BV FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Masena Invest, BV is registered with the FDA (registration 3012312061) in Dordrecht Zuid-Holland, Netherlands. It lists 7 device types. The FDA files 17 510(k) clearances under its listings, the newest dated February 22, 2019. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Masena Invest, BV

FDA registration number: 3012312061
Address: Burgemeester de Raadtsingel 71, Dordrecht Zuid-Holland, Netherlands, 3311 JG
Owner or operator: Masena Invest, BV (10052668)
Roles: Specification developer
First device listed: September 6, 2016
Registered through: 2026
Brand names listed: FK-127-co, NCT-336BLACK, iProven NCT- 336BLUE

Devices it lists

Device	Product code	Class	Role	Source
Continuous Measurement Thermometer	FLL	2	Specification developer	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Specification developer	accessdata.fda.gov
Oximeter	DQA	2	Specification developer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Specification developer	accessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The Counter	NGE	1	Specification developer	accessdata.fda.gov
Thermometer, Clinical Mercury	FLK	2	Specification developer	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Specification developer	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
February 22, 2019	K181551	DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette	LCX	Substantially Equivalent	Runbio Biotech Co.,Ltd	accessdata.fda.gov
January 2, 2019	K181215	Infrared Thermometer	FLL	Substantially Equivalent	Shenzhen Finicare Co., Ltd.	accessdata.fda.gov
July 23, 2018	K171888	Non-contact infrared body thermometer	FLL	Substantially Equivalent	Hetaida Technology Co., Ltd.	accessdata.fda.gov
March 28, 2018	K172627	David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette	LCX	Substantially Equivalent	Runbio Biotech Co.,Ltd	accessdata.fda.gov
March 14, 2018	K172795	Infrared Thermometer	FLL	Substantially Equivalent	Shenzhen Jumper Medical Equipment Co., Ltd.	accessdata.fda.gov
May 27, 2016	K153149	Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36	FLL	Substantially Equivalent	Sejoy Electronics & Instruments Co., Ltd.	accessdata.fda.gov
August 28, 2014	K140582	FINGERTIP PULSE OXIMETER	DQA	Substantially Equivalent	Shenzhen Jumper Medical Equipment Co., Ltd.	accessdata.fda.gov
November 12, 2013	K132085	ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM	LCX	Substantially Equivalent	Co-Innovation Biotech Co., Ltd.	accessdata.fda.gov
November 12, 2013	K131243	NON-CONTACT INFRARED THERMOMETER	FLL	Substantially Equivalent	Shenzhen Jumper Medical Equipment Co., Ltd.	accessdata.fda.gov
June 19, 2013	K131395	TRANSTEK BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	Guangdong Transtek Medical Electronics Co., Ltd.	accessdata.fda.gov
December 21, 2012	K123669	TRANSTEK WRIST BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	Zhongshan Transtek Electronics Co., Ltd.	accessdata.fda.gov
November 7, 2012	K122912	DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)	FLL	Substantially Equivalent	Hangzhou Hua'An Medical & Health Instruments Co.,	accessdata.fda.gov
October 22, 2012	K122482	TRANSTEK WRIST BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	Zhongshan Transtek Electronics Co., Ltd.	accessdata.fda.gov
December 16, 2011	K112289	DISPOSABLE THERMOMETER COVERS AND SHEATHS	FLL	Substantially Equivalent	Kang ZE Industrial Co. Limited	accessdata.fda.gov
January 7, 2010	K092447	DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES	FLL	Substantially Equivalent	Hangzhou Hua'An Medical & Health Instruments Co.,	accessdata.fda.gov
July 18, 2006	K053236	DAVID PREGNANCY TEST (MIDSTREAM)	LCX	Substantially Equivalent	Runbio Biotech Co.,Ltd	accessdata.fda.gov
February 17, 2006	K060019	ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)	LCX	Substantially Equivalent	Artron Laboratories, Inc.	accessdata.fda.gov

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Updated February 22, 2019. 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.