HUVITZ CO., LTD.

Korea, Republic · Anyang-Si

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, 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

15listed device types

Class I 8Class II 7Class III 0

plus 20 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

20registered devices

Class I 10Class II 10

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

SASaudi ArabiaSFDA

15registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

23 including historic records

TWTaiwanTFDA

25valid device licences

Class I 11Class II 14

SGSingaporeHSA SMDR

11device registrations

CLASS B 11

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

Class I 4IIa 3Class Im (measuring) 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

16registrations

RURussiaRoszdravnadzor

19active registrations

Class 1 3Class 2a 16

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 States20 registration records, 6 510(k), 0 PMA, 1 excluded

Brazil20 confirmed, 1 excluded

Saudi Arabia15 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: HUVITZ CO., LTD. · HUVITZ CO LTD · Huvitz Co., Ltd. · Huvitz Co Ltd

FDA 510(k) clearances by year

12008 · K073190

12009 · K093639

12017 · K161829

12019 · K191615

12021 · K202097

12023 · K232143

FDA listed device types

showing 8 of 15

Chart, Visual Acuity 1Refractor, Manual, Non-Powered, Including Phoropter 1Topographer, Corneal, Ac-Powered 1Projector, Ophthalmic 1Refractometer, Ophthalmic 1Instrument, Measuring, Lens, Ac-Powered 1Table, Instrument, Powered, Ophthalmic 1Perimeter, Automatic, Ac-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232143	Applanation Tonometer HT-5000	2023-10-23
US	K202097	Fundus Camera	2021-02-02
US	K191615	Huvitz Imaging System	2019-07-18
BR	81325999065	Tonômetro de Aplanação	Class II
BR	81325990386	Rastreador de visão	Class I
BR	81325990415	Projetor de gráficos	Class I
SA	ME0000004441SFDAA00001	Huvitz Digital Chart	—
SA	ME0000004441SFDAA00002	Huvitz Slit Lamp	—
CA	71161	DIGITAL REFRACTOR	Class II
CA	71162	AUTO REFRACTO-KERATOMETER	Class II
CA	74735	AUTO REF-KERATOMETER HRK-7000	Class II

HUVITZ CO., LTD.

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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