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Mallinckrodt Inc., Liebel-Flarsheim Business

USA · Cincinnati

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

5listed device types

Class I 1Class II 4Class III 0

plus 14 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

17active device licences

Class II 17

23 including historic records

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 States14 registration records, 11 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Canada17 confirmed, 0 excluded

Manufacturer names merged into this page: Liebel-Flarsheim Company LLC · LIEBEL-FLARSHEIM COMPANY LLC · LIEBEL-FLARSHEIM CANADA INC. · LIEBEL FLARSHEIM COMPANY LLC

Same-named companies — This database also contains companies with near-identical names: Liebel-Flarsheim Company, LLC, LIEBEL-FLARSHEIM CANADA INC.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11997

11999

12002

12003

12004

12007

12008

12009

12012

12016

12020

FDA listed device types

Injector, Contrast Medium, Automatic 1Injector And Syringe, Angiographic 1Stopcock, I.V. Set 1Syringe, Piston 1Stand, Infusion 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K193010	Liebel-Flarsheim IBP Transfer Set	2020-11-18
US	K152361	OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System	2016-01-14
US	K121838	LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM	2012-07-11
BR	80136719001	READY-BOX	Class I
CA	5435	HANDI-FIL	Class II
CA	6547	EXTENSION TUBES	Class II
CA	11646	CT 9000 CONTRAST DELIVERY SYSTEM	Class II

Mallinckrodt Inc., Liebel-Flarsheim Business

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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