HomeUSAAceso Laboratories, Inc.

Aceso Laboratories, Inc.

USA · Chino
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, 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
59listed device types
Class I 22Class II 35Class III 0unclassified 2
plus 47 registration records and 1 510(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
8 including historic records
TWTaiwanTFDA
12valid device licences
Class I 12
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 States47 registration records, 1 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: ACESO LABORATORIES INC. · ACESO LABORATORIES, INC.

Company information

Country
USA
City
Chino

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

12024 · K234152

FDA listed device types

showing 8 of 59
Test, Luteinizing Hormone (Lh), Over The Counter 1Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) 1Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Enzyme Linked Immunoabsorbent Assay, Rotavirus 1Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) 1Automated Urinalysis System 1Nitroprusside, Ketones (Urinary, Non-Quant.) 1Radioimmunoassay, Luteinizing Hormone 1

Registration details (sample)

MarketIdentifierNameClass / date
USK234152ACESO Early Pregnancy Test2024-04-05

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