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VISIA imaging S.r.l.

Italy · San Giovanni Valdarno

✓ 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

9listed device types

Class I 6Class II 3Class III 0

plus 11 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

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

1active device licences

Class II 1

7 including historic records

TWTaiwanTFDA

6valid device licences

Class I 3Class II 3

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

4active ARTG entries

Class I 2IIa 2

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

2active registrations

Class 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 States11 registration records, 4 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 1 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: VISIA imaging S.r.l. · VISIA IMAGING S.R.L.

FDA 510(k) clearances by year

12014 · K131567

12016 · K160327

12022 · K211868

12023 · K222933

FDA listed device types

showing 8 of 9

Biomicroscope, Slit-Lamp, Ac-Powered 1Camera, Ophthalmic, Ac-Powered 1Device, Analysis, Anterior Segment 1Chart, Visual Acuity 1Topographer, Corneal, Ac-Powered 1Refractometer, Ophthalmic 1Instrument, Measuring, Lens, Ac-Powered 1Keratoscope, Ac-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K222933	MYAH	2023-06-29
US	K211868	MYAH	2022-03-01
US	K160327	ALADDIN HW3.0	2016-10-05
BR	80117580570	Biometer	Class II
BR	80117581197	Henson 9000	Class I
BR	80117589036	Integrated Device Corneal Analyzer and Ocular Biometer	Class II
CA	95001	ALADDIN TMS	Class II