VITREQ B.V.

Netherlands · Vierpolders Zuid-Holland

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, South Korea, Australia, Israel, Russia — 8 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

11listed device types

Class I 7Class II 4Class III 0

plus 9 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 1Class II 7

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

SASaudi ArabiaSFDA

40registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

4valid device licences

Class I 3Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

12active ARTG entries

Class I 5IIa 6Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 States9 registration records, 2 510(k), 0 PMA

Brazil8 confirmed, 0 excluded

Saudi Arabia40 confirmed, 0 excluded

Manufacturer names merged into this page: VITREQ BV · VITREQ B.V · VITREQ B.V. · Vitreq B.V.

FDA 510(k) clearances by year

12019 · K182646

12020 · K202038

FDA listed device types

showing 8 of 11

Spatula, Ophthalmic 1Cannula, Ophthalmic 1Depressor, Orbital 1Forceps, Ophthalmic 1Needle, Aspiration And Injection, Disposable 1Adaptor, Bulbs, Miscellaneous, For Endoscope 1Scissors, Ophthalmic 1Photocoagulator And Accessories 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K202038	CryoTreQ	2020-12-30
US	K182646	Vitreq disposable laser probes, light fibers and Chandelier	2019-05-01
BR	81346509023	Cânulas Tipo Backflush	Class II
BR	81346509024	Cânulas Oftalmológicas VitreQ	Class II
BR	81346509007	Fibra de Luz VitreQ	Class II
SA	ME0000004746SFDAA00001	Williamson scleral depressor	—
SA	ME0000004746SFDAA00002	Universal Backflush Instrument	—

VITREQ B.V.

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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