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PALL MEDICAL

USA · Marlborough MA · www.pall.com

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, Israel, Russia — 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

0UDI-DI device records

USUnited StatesFDA openFDA

6510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

23registered device records

Class I 2Class IIa 19Class IIb 2

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

33 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

3active registrations

Class 1 2Class 2a 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.

European Union63 raw hits, 63 excluded, 0 confirmed

United States0 registration records, 6 510(k), 0 PMA, 8 excluded

United Kingdom23 confirmed, 2 excluded

Brazil11 confirmed, 0 excluded

Canada14 confirmed, 2 excluded

Manufacturer names merged into this page: PALL MEDICAL - CRITICAL CARE (A DIVISION OF PALL CORPORATION) · PALL MEDICAL A DIVISION OF PALL INTERNATIONAL SARL · PALL MEDICAL, A DIVISION OF PALL INTERNATIONAL SARL

Regulatory identity

UK responsible person: Global Life Sciences Solutions Operations UK Ltd.

Registration details (sample)

Market	Identifier	Name	Class / date
UK	46816	Breathing Filters	Class IIa
UK	46816	Breathing Filters	Class IIa
UK	46816	Breathing Filters	Class IIa
US	K033991	MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET	2004-01-22
US	K030469	LAPAROSHIELD CONDITIONED INSUFFLATION SET	2003-05-09
US	K013093	PALL ULTIPOR ANESTHESIA BREATHING SYSTEM	2002-08-01
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 MEDICAL

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

Registration details (sample)

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