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CRYSTALVUE MEDICAL CORPORATION

Taiwan · Taoyuan City

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, 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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 1Class II 5Class III 0

plus 11 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 3

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 States11 registration records, 3 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: CRYSTALVUE MEDICAL CORPORATION · Crystalvue Medical Corporation

FDA 510(k) clearances by year

12018 · K180820

12019 · K182199

12021 · K210197

FDA listed device types

Medical Device Data System 1Tonometer, Ac-Powered 1Camera, Ophthalmic, Ac-Powered 1Dilator, Vaginal 1Ophthalmoscope, Ac-Powered 1Tomography, Optical Coherence 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K210197	NFC-600 Automated Portable Retinal Camera	2021-04-13
US	K182199	NFC-700 non-mydriatic auto fundus camera	2019-01-02
US	K180820	Tono Vue Non-Contact Tonometer	2018-12-14
BR	80117589032	Automated Portable Retina Camera	Class II
BR	80117589035	Non-contact Tonometer	Class II
BR	80117589033	Auto Non-mydriatic Fundus Camera	Class II

CRYSTALVUE MEDICAL 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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