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BOEHRINGER LABORATORIES, LLC

USA · Phoenixville

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 7 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

7listed device types

Class I 3Class II 4Class III 0

plus 10 registration records and 44 510(k)

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

11active device licences

Class II 11

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States10 registration records, 44 510(k), 0 PMA, 6 excluded

Canada11 confirmed, 1 excluded

Manufacturer names merged into this page: BOEHRINGER LABORATORIES, LLC

FDA 510(k) clearances by year

31979

11980

21983

31985

31986

21988

11989

31990

21991

21993

41994

11995

11996

32002

22006

12013

22015

22024

12025

12026

FDA listed device types

Collector, Urine, Powered, Non Indwelling Catheter 1Mask, Oxygen, Low Concentration, Venturi 1Restraint, Protective 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Regulator, Vacuum 1Laparoscope, General & Plastic Surgery 1Tubes, Gastrointestinal (And Accessories) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261890	52Fr ViSiGi LUX; 52Fr ViSiGi 3D®	2026-08-14
US	K243399	Boehringer Laboratories Liver Retractor	2025-07-02
US	K234033	ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)	2024-05-06
CA	4594	BRONCHODILATOR TEE	Class II
CA	4596	INSPIRATORY FORCE METER AND ACCESSORIES	Class II
CA	4597	SCAVENGING POP OFF VALVE	Class II

BOEHRINGER LABORATORIES, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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