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ASTORIA-PACIFIC, INC.

USA · Clackamas

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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

14listed device types

Class I 8Class II 6Class III 0

plus 21 registration records and 9 510(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

1 including historic records

TWTaiwanTFDA

0valid device licences

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 States21 registration records, 9 510(k), 0 PMA

Manufacturer names merged into this page: ASTORIA-PACIFIC, INC.

FDA 510(k) clearances by year

11997

11998

11999

12001

12008

12009

22011

12013

FDA listed device types

showing 8 of 14

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine 1Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase 1System, Test, Biotinidase 1Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative 1Radioimmunoassay, Thyroid-Stimulating Hormone 1Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine 11-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine 1Colorimeter, Photometer, Spectrophotometer For Clinical Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K121101	SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT	2013-06-20
US	K102643	SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT	2011-07-15
US	K101392	NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D	2011-02-04

ASTORIA-PACIFIC, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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