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Phadia US, Inc.

USA · Portage

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

52listed device types

Class I 24Class II 28Class III 0

plus 78 registration records and 22 510(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

0active device licences

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 States78 registration records, 22 510(k), 0 PMA, 4 excluded

Brazil0 confirmed, 2 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: PHADIA US INC.

FDA 510(k) clearances by year

22006

32007

12008

32009

32010

22011

32012

22013

22014

12015

FDA listed device types

showing 8 of 52

System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens 1Anti-Rnp Antibody, Antigen And Control 1Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) 1Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use 1Reagent, Borrelia Serological Reagent 1System, Test, Rheumatoid Factor 1Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody 1Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K141375	ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250	2015-02-13
US	K140225	ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO	2014-10-27
US	K132631	EIA SMDP IMMUNOASSAY	2014-08-29

Phadia US, Inc.

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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