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Liebel-Flarsheim Company, LLC

USA · Cincinnati

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Russia — 9 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

14valid device licences

Class I 2Class II 12

SGSingaporeHSA SMDR

7device registrations

CLASS C 7

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

5active ARTG entries

Class I 1IIa 1IIb 3

HKHong KongMDACS

2valid listings

Class II 1Class III 1

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

3active registrations

Class 2a 2Class 2b 1

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 CANADA INC., Mallinckrodt Inc., Liebel-Flarsheim Business. Company name alone cannot separate their registrations, so the figures below may include either.

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

Liebel-Flarsheim Company, 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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