HomeFranceMauna Kea Technologies, Inc.

Mauna Kea Technologies, Inc.

France · Paris
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Singapore, 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
3listed device types
Class I 0Class II 3Class III 0
plus 16 registration records and 19 510(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
3active device licences
Class II 3
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
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 States16 registration records, 19 510(k), 0 PMA, 1 excluded
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: MAUNA KEA TECHNOLOGIES

Company information

Country
France
City
Paris

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

12005
12006
12011
22012
12013
22014
22015
12016
22017
12018
12019
22020
12021
12022

FDA listed device types

Confocal Optical Imaging 1Endoscope, Neurological 1Laparoscope, General & Plastic Surgery 1

Registration details (sample)

MarketIdentifierNameClass / date
USK220477Cellvizio 100 series system with confocal Miniprobes2022-04-11
USK212322Cellvizio I.V.E. system with Confocal Miniprobes2021-08-18
USK193416Cellvizio I.V.E. with Confocal Miniprobes2020-02-28
CA73470CELLVIZIO - LUNGClass II
CA73472CELLVIZIO - GIClass II
CA89135CELLVIZIO 100 SERIES WITH CONFOCAL MINIPROBESClass II

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