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LAB VISION CORPORATION

USA · Fremont

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Canada — 3 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

6listed device types

Class I 6Class II 0Class III 0

plus 10 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

5active device licences

Class II 5

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States10 registration records, 2 510(k), 0 PMA, 230 excluded

Brazil0 confirmed, 34 excluded

Saudi Arabia1 confirmed, 23 excluded

Canada5 confirmed, 27 excluded

Manufacturer names merged into this page: Vision Rx Lab Pvt. Ltd. · VISION RX LAB AMERICA LLC · VISION LAB CO, LLC · LAB VISION CORPORATION · Vision Rx Lab L.L.C

FDA 510(k) clearances by year

22006 · K061360

FDA listed device types

Spectacle, Magnifying 1Lens, Spectacle (Prescription), For Reading Discomfort 1Lens, Spectacle, Non-Custom (Prescription) 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1Sunglasses (Non-Prescription Including Photosensitive) 1Frame, Spectacle 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K061360	NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)	2006-06-27
US	K060462	NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2)	2006-04-24
SA	ME0000007383SFDAA00001	BLUEMAX	—
CA	81683	THYROGLOBULIN AB-6 (COCKTAIL)	Class II
CA	81696	PSMA (SP29)	Class II
CA	81705	TTF-1 AB-1 (8G7G3 / 1)	Class II

LAB VISION 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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