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WELCH ALLYN GMBH & CO. KG

USA · Branchburg

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

55listed device types

Class I 17Class II 38Class III 0

plus 124 registration records and 120 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

52registered devices

Class I 40Class II 12

54 including historic records

SASaudi ArabiaSFDA

7registered imported devices

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

CACanadaMDALL

44active device licences

Class II 41Class III 2Class IV 1

186 including historic records

TWTaiwanTFDA

22valid device licences

Class I 9Class II 13

SGSingaporeHSA SMDR

20device registrations

CLASS B 16CLASS C 4

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

54active ARTG entries

Class I 33IIa 13IIb 4Class Im (measuring) 4

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

32registrations

RURussiaRoszdravnadzor

23active registrations

Class 1 2Class 2a 16Class 2b 5

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 States124 registration records, 120 510(k), 0 PMA

Brazil52 confirmed, 0 excluded

Saudi Arabia7 confirmed, 0 excluded

Canada44 confirmed, 0 excluded

Manufacturer names merged into this page: WELCH ALLYN, INC. · WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V. · WELCH ALLYN PROTOCOL, INC. · WELCH ALLYN INC. · MEDICAL RESEARCH LOBORATORIES, INC. A WELCH ALLYN COMPANY · WELCH ALLYN, INC

Same-named companies — This database also contains companies with near-identical names: WELCH ALLYN DO BRASIL, COMÉRCIO DE EQUIPAMENTOS MÉDICOS LTDA, WELCH ALLYN, CARDIO CONTROL BV, WELCH ALLYN MEDICAL PRODUCTS, WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

52001

62002

52003

52004

52005

22006

52007

12009

32010

22011

62012

22013

32014

12017

12018

12019

12022

12023

12024

12025

FDA listed device types

showing 8 of 55

System, Network And Communication, Physiological Monitors 1Detector And Alarm, Arrhythmia 1Electrocardiograph, Ambulatory (Without Analysis) 1Ophthalmoscope, Ac-Powered 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Continuous, Ventilator, Home Use 1System, Image Management, Ophthalmic 1Ventilator, Continuous, Facility Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243598	Welch Allyn Connex® 360 (Multiple)	2025-07-13
US	K241411	Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)	2024-12-20
US	K223381	iExaminer System with Panoptic Plus	2023-03-15
BR	80011680091	Capa Protetora de Sonda ThermoScan	Class I
BR	80145240457	Capa Protetora de Sonda	Class I
BR	80145240458	Capa Protetora de Sonda para Termômetro de Ouvido	Class I
SA	ME0000001408SFDAA00196	VAGINAL SPECULUM LIGHTING SYSTEM	—
SA	ME0000001408SFDAA00197	KleenSpec ®Single Use LED Vaginal Speculum	—
CA	64154	WELCH ALLYN AED 10	Class III
CA	64155	WELCH ALLYN PIC DEFIBRILLATORS	Class IV
CA	69808	BITRODE ELECTROCARDIOGRAPH (ECG) LIMB ELECTRODE	Class II