HomeCanadaMolecuLight, Inc.

MolecuLight, Inc.

Canada · Toronto
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, South Korea, Australia, Hong Kong, Israel — 7 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
4listed device types
Class I 1Class II 3Class III 0
plus 5 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
2 including historic records
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
4active ARTG entries
Class I 3IIa 1
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
2registrations
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 States5 registration records, 5 510(k), 0 PMA
Manufacturer names merged into this page: MOLECULIGHT INC.

Company information

Country
Canada
City
Toronto

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

12018 · DEN180008
12019 · K191371
22021 · K211901
12022 · K213840

FDA listed device types

Autofluorescence Imaging Adjunct Tool For Wounds 1General Surgery Tray 1Drape, Surgical, Exempt 1Tape, Camera, Surgical 1

Registration details (sample)

MarketIdentifierNameClass / date
USK213840MolecuLight I:X2022-05-18
USK211901MolecuLightDX2021-07-21
USK210882MolecuLight I:X2021-06-22

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