Home›Sweden›PHADIA GMBH

PHADIA GMBH

Sweden · Uppsala

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

30listed device types

Class I 8Class II 22Class III 0

plus 113 registration records and 34 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

128registered devices

Class I 12Class II 116

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

36active device licences

Class II 36

50 including historic records

TWTaiwanTFDA

88valid device licences

Class I 13Class II 74未分级 1

SGSingaporeHSA SMDR

51device registrations

CLASS B 51

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

7active ARTG entries

IVD Class 1 4IVD Class 2 3

HKHong KongMDACS

24valid listings

IVD B 23IVD C 1

ILIsraelAMAR

10registrations

RURussiaRoszdravnadzor

4active registrations

Class 1 2Class 2a 2

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 States113 registration records, 34 510(k), 0 PMA, 2 excluded

Brazil128 confirmed, 1 excluded

Canada36 confirmed, 0 excluded

Manufacturer names merged into this page: PHADIA AB · PHADIA GMBH

FDA 510(k) clearances by year

12007

22009

12010

12011

32013

22014

12015

42016

12017

82018

32019

12020

32021

22022

12026

FDA listed device types

showing 8 of 30

System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens 1Anti-Rnp Antibody, Antigen And Control 1Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) 1System, Test, Rheumatoid Factor 1Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody 1Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) 1System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) 1Extractable Antinuclear Antibody, Antigen And Control 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253367	EliA CTD 13 Screen	2026-06-25
US	K212181	ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed	2022-08-03
US	K210902	EliA Ro52, EliA Ro60	2022-07-27
BR	80254180110	ImmunoCAP Specific IgA/IgG sample diluent	Class I
BR	80254180136	EliA MPOs Well	Class II
BR	80254180303	Família EliA ASCA Control	Class II
CA	342	UNICAP TOTAL IGE	Class II
CA	403	UNICAP TRYPTASE	Class II
CA	665	PHADEBAS AMYLASE TEST	Class II