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Home›USA›Minimally Invasive Surgical Technologies, Inc.

Minimally Invasive Surgical Technologies, Inc.

USA · Great Neck
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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 1Class II 1Class III 0unclassified 1
plus 3 registration records and 11 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class II 4
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
pendingnot queried
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 States3 registration records, 11 510(k), 0 PMA
Brazil4 confirmed, 0 excluded
Manufacturer names merged into this page: Hunan Handlike Minimally Invasive Surgery Co., Ltd. · HUNAN HANDLIKE MINIMALLY INVASIVE SURGERY CO.,LTD · CHANGZHOU BLON MINIMALLY INVASIVE MEDICAL DEVICES TECHNOLOGY CO. LTD.
Same-named companies — This database also contains companies with near-identical names: Hunan Handlike Minimally Invasive Surgery Co., Ltd., Minimally Invasive Devices, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Great Neck

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

51993
11995
12008
12010
12015
12018
12024

FDA listed device types

Instrument, Ultrasonic Surgical 1Electrosurgical, Cutting & Coagulation & Accessories 1Laparoscopic Accessories, Gynecologic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK233036Ultrasonic Surgical System2024-06-18
USK171825Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument2018-02-13
USK150705FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator2015-04-13
BR82324749041PINÇAS CIRÚRGICASClass II
BR83075439002EMPUNHADURA PROClass II
BR82324749036EMPUNHADURA PROClass II

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