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Pall International, Sarl

Switzerland · Fribourg

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel — 6 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

9listed device types

Class I 1Class II 8Class III 0

plus 19 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

11registered devices

Class I 1Class II 10

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

14active device licences

Class II 9Class III 5

32 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

12device registrations

CLASS B 12

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

9active ARTG entries

IIa 7IIb 1Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States19 registration records, 2 510(k), 0 PMA, 7 excluded

Brazil11 confirmed, 0 excluded

Canada14 confirmed, 3 excluded

Manufacturer names merged into this page: Pall International, Sarl · PALL MEDICAL A DIVISION OF PALL INTERNATIONAL SARL · PALL MEDICAL, A DIVISION OF PALL INTERNATIONAL SARL

FDA 510(k) clearances by year

12016 · K153434

12017 · K163609

FDA listed device types

showing 8 of 9

Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Filter, Bacterial, Breathing-Circuit 1Filter, Infusion Line 1System, Water Purification, General Medical Use 1Cord Blood Processing System And Storage Container 1Spirometer, Diagnostic 1Syringe, Piston 1Apparatus, Exhaust, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K163609	Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)	2017-06-01
US	K153434	Pall-Aquasafe Water Filter	2016-06-10
BR	10175859017	Gardian 25 mm - Filtro de Seringa	Class II
BR	10175859001	Ultipor 25 Filtro para Sistema Respiratório	Class II
BR	10175859002	Ultipor 25 Filtro para Sistema Respiratório - Estéril	Class II
CA	5849	PALL GAS LINE FILTER	Class II
CA	13697	PALL LEUKOGUARD BC BLOOD CARDIOPLEGIA FILTER	Class III
CA	13699	PALL PRE-BYPASS PLUS FILTER	Class III

Pall International, Sarl

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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