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PHC Corporation

✓ Record-verifiedregistrations found in 10 marketsEU SRN JP-MF-000008516

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Singapore, South Korea, Australia, 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

36UDI-DI device records

Class I 4Class IIa 12IVD A 7IVD C 13

USUnited StatesFDA openFDA

15listed device types

Class I 2Class II 11Class III 2

plus 49 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

19registered device records

Class I 2Class IIa 6IVD general 11

BRBrazilANVISA

8registered devices

Class I 3Class II 5

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

2valid device licences

Class I 2

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

5GMP quality-system certificates

Import 2IVD import 3

AUAustraliaTGA ARTG

5active ARTG entries

IIa 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

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.

European Union36 raw hits, 0 excluded, 36 confirmed

United States49 registration records, 1 510(k), 0 PMA, 1 excluded

United Kingdom19 confirmed, 0 excluded

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: PHC Corporation · PHC CORPORATION

Regulatory identity

EU manufacturer SRN: JP-MF-000008516
EU authorised representative: PHC Europe B.V.
UK responsible person: AB Scientific Ltd

Business registration

Legal name: PHC Holdings Corporation
Corporate Number: 6010001155349
Registration status: Active
Registered capital: JPY 49,114,000,000

Business registration data from EDINET (Japan FSA), retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12024 · K231974

FDA listed device types

showing 8 of 15

Automated Insulin Dosing , Threshold Suspend 1Automated Insulin Dosing Device System, Single Hormonal Control 1Myoglobin, Antigen, Antiserum, Control 1Calibrator, Secondary 1Fibrin Split Products 1Immunoassay Method, Troponin Subunit 1Accessory, Assisted Reproduction, Exempt 1System, Test, C-Reactive Protein 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04987595302008	PATHFAST Presepsin Control	IVD C
EU	04987595302107	PATHFAST B･R･A･H･M･S PCT Control	IVD C
EU	04987595301940	PATHFAST TB LAM Ag Control	IVD C
EU	04987595301117	PATHFAST cTnI	IVD C
UK	47351	PATHFAST NTproBNP	IVD general
UK	53707	PATHFAST hsCRP	IVD general
UK	56701	PATHFAST Instrument	IVD general
US	K231974	PATHFAST®hs-cTnI-II	2024-03-20
BR	80159760011	REFRIGERADOR LABORATORIAL	Class II
BR	80159760006	FREEZER LABORATORIAL	Class II
BR	80241710008	FREEZER BIOMÉDICO (TEMPERATURA ULTRA BAIXA - 86°C	Class II