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Mallinckrodt Manufacturing, LLC

USA · Madison

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, South Korea, Australia — 4 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

10listed device types

Class I 4Class II 6Class III 0

plus 24 registration records and 4 510(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

2active device licences

Class II 1Class III 1

13 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

IIa 1IIb 1

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 States24 registration records, 4 510(k), 0 PMA, 15 excluded

Brazil0 confirmed, 3 excluded

Canada2 confirmed, 6 excluded

Manufacturer names merged into this page: Mallinckrodt Manufacturing LLC · MALLINCKRODT MANUFACTURING LLC

FDA 510(k) clearances by year

12020 · K200389

22023 · K222930

12025 · K242578

FDA listed device types

showing 8 of 10

System, Rebreathing, Radionuclide 1Analyzer, Nitric Oxide 1Ventilatory Effort Recorder 1Apparatus, Nitric Oxide, Backup Delivery 1Analyzer, Nitrogen Dioxide 1Apparatus, Nitric Oxide Delivery 1Gas, Calibration (Specified Concentration) 1Set, Tubing And Support, Ventilator (W Harness) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242578	EVOLVE Nitric Oxide Delivery System	2025-01-03
US	K222930	Evolve Nitric Oxide Delivery System	2023-12-06
US	K211153	Inomax DSIR	2023-04-20
CA	12349	INOVENT NITRIC OXIDE DELIVERY SYSTEM	Class III
CA	80533	INOCAL CALIBRATION GAS	Class II

Mallinckrodt Manufacturing, 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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