Home›USA›Bayer Healthcare, Diagnostics Division

Bayer Healthcare, Diagnostics Division

USA · Tarrytown

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 2Class III 1

plus 3 registration records and 91 510(k), 8 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States3 registration records, 91 510(k), 8 PMA, 10 excluded

Brazil0 confirmed, 4 excluded

Canada0 confirmed, 6 excluded

Manufacturer names merged into this page: Bayer HealthCare, LLC

FDA 510(k) clearances by year

12000

52001

212002

212003

82004

122005

62006

12007

12008

32009

12010

52012

12013

12014

32015

12018

FDA listed device types

Transcervical Contraceptive Tubal Occlusion Device 1Introducer, Syringe Needle 1Injector And Syringe, Angiographic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K171802	ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)	2018-03-07
US	K152852	ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)	2015-12-22
US	K150942	Contour Next USB Blood Glucose Monitoring System	2015-11-25

Bayer Healthcare, Diagnostics Division

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies