HomeUSADESIGNS FOR VISION, INC.

DESIGNS FOR VISION, INC.

USA · Bohemia
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Israel, Russia — 6 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
5listed device types
Class I 5Class II 0Class III 0
plus 5 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
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
TWTaiwanTFDA
3valid device licences
Class I 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
Class I 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
2active registrations
Class 1 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 States5 registration records, 5 510(k), 0 PMA, 72 excluded
Brazil1 confirmed, 2 excluded
Saudi Arabia0 confirmed, 3 excluded
Canada0 confirmed, 5 excluded
Manufacturer names merged into this page: DESIGNS FOR VISION, INC. · DESIGNS FOR VISION INC

Company information

Country
USA
City
Bohemia

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11980 · K801058
12001 · K013880
12003 · K032283
22005 · K051786

FDA listed device types

Loupe, Diagnostic/Surgical 1Wound Autofluorescence Imaging Device 1Telescope, Spectacle, Low-Vision 1Camera, Surgical And Accessories 1Headlamp, Operating, Battery-Operated 1

Registration details (sample)

MarketIdentifierNameClass / date
USK051786MELIDE FIBEROPTIC LIGHT2005-08-15
USK043530DVI CURING LIGHT2005-01-25
USK032283DESIGNS FOR VISION FIBEROPTIC LIGHT2003-08-20
BR81704230001lupas designs for visionClass I

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