Home›USA›Advanced Instruments, Inc.

Advanced Instruments, Inc.

USA · Norwood

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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

9listed device types

Class I 6Class II 3Class III 0

plus 8 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 2Class II 5

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

1active device licences

Class II 1

17 including historic records

TWTaiwanTFDA

3valid device licences

Class I 2Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

IVD Class 1 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States8 registration records, 16 510(k), 0 PMA, 260 excluded

Brazil7 confirmed, 33 excluded

Saudi Arabia0 confirmed, 10 excluded

Canada1 confirmed, 27 excluded

Manufacturer names merged into this page: Advanced Instruments, LLC · ADVANCED INSTRUMENTS, LLC · ADVANCED INSTRUMENTS, INC

FDA 510(k) clearances by year

21979

11981

11983

11984

11985

11986

11987

11991

21993

11996

11997

12011

12012

12016

FDA listed device types

showing 8 of 9

Counter, Cell, Automated (Particle Counter) 1Mixture, Hematology Quality Control 1Diazo Colorimetry, Bilirubin 1Colorimeter, Photometer, Spectrophotometer For Clinical Use 1Container, Specimen, Non-Sterile 1Osmometer For Clinical Use 1Dish, Tissue Culture 1Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K152776	Glocyte Automated Cell Counter System	2016-05-27
US	K120631	PATIENT MONITOR	2012-05-25
US	K112465	VITAL SIGNS MONITOR	2011-09-14
BR	10301160133	Família CLINITROL	Class I
BR	10301160135	Osmolality Linearity Set, REF: 3LA028	Class II
BR	10301160137	RENOL, REF: 3LA085	Class II
CA	71010	TEAR OSMOMETER REFERENCE SOLUTION	Class II

Advanced Instruments, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies