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HOYA Corporation

Bulgaria · Plovdiv

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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

1listed device types

Class I 0Class II 1Class III 0

plus 1 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

26registered devices

Class I 1Class II 25

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

12registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

4valid device licences

Class I 1Class II 3

SGSingaporeHSA SMDR

41device registrations

CLASS B 41

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

40active ARTG entries

Class I 18IIa 18IIb 3Class Is (sterile) 1

HKHong KongMDACS

10valid listings

Class II 8Class III 2

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

39active registrations

Class 2a 38Class 3 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.

United States1 registration records, 1 510(k), 0 PMA, 34 excluded

Brazil26 confirmed, 1 excluded

Saudi Arabia12 confirmed, 3 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: HOYA Corporation · HOYA CORPORATION · Hoya Corporation · Hoya corporation

Registration details (sample)

Market	Identifier	Name	Class / date
US	K120602	APACERAM BONE GRAFT SUBSTITUTE	2012-03-23
BR	10371280042	Videoprocessadoras EPK Séries	Class II
BR	80011680013	FIBROCOLONOSCOPIO PENTAX	Class I
BR	10371289003	Sistema de assistência inteligente PENTAX Medical SAS-M10	Class II
SA	ME0000001890SFDAA00003	Pentax Medical Smart Assistant System	—
SA	ME0000001890SFDAA00003	Pentax Medical Smart Assistant System	—

HOYA Corporation

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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