HomeUSAAalto Scientific, Ltd.

Aalto Scientific, Ltd.

USA · Eatonton
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Israel — 4 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
7listed device types
Class I 6Class II 1Class III 0
plus 7 registration records and 35 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
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
8active device licences
Class II 8
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States7 registration records, 35 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Canada8 confirmed, 0 excluded
Manufacturer names merged into this page: AALTO SCIENTIFIC LTD. · AALTO SCIENTIFIC, LTD.

Company information

Country
USA
City
Eatonton

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

11982
31995
11996
12002
12003
12004
12006
12007
22008
62010
42011
42012
32013
22014
22015
12016
12017

FDA listed device types

Controls For Blood-Gases, (Assayed And Unassayed) 1Enzyme Controls (Assayed And Unassayed) 1Multi-Analyte Controls, All Kinds (Assayed) 1Antigens, Cf (Including Cf Control), Adenovirus 1-33 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Kit, Serological, Positive Control 1Plasma, Coagulation Control 1

Registration details (sample)

MarketIdentifierNameClass / date
USK163629Audit MicroControls Linearity FD Tumor Markers II2017-03-10
USK161874Audit MicroControls Linearity DROP LQ Blood Glucose2016-08-10
USK143571Audit MicroControls Linearity LQ Cystatin-C2015-01-23
BR10387650128CONTROL LQ GLYCOHEMOGLOBIN A1CClass II
BR10387650129CONTROL FD GLYCOHEMOGLOBIN A1CClass II
BR10387650131Família CONTROL FD URINE CHEMISTRYClass II
CA99824RF/CRP LINEARITY CONTROLSClass II
CA99860LINEARITY FD FERTILITY SIEMENS CENTAURClass II
CA99973LINEARITY FD GENERAL CHEMISTRYClass II

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