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Phamatech, Inc.

USA · San Diego

✓ 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

19listed device types

Class I 3Class II 13Class III 0unclassified 3

plus 18 registration records and 62 510(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

1active device licences

Class II 1

2 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 States18 registration records, 62 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: PHAMATECH INC. · PHAMATECH, INC.

FDA 510(k) clearances by year

11996

71997

81998

161999

32000

152001

12002

12003

32004

22005

22007

12012

12014

12018

FDA listed device types

showing 8 of 19

Enzyme Immunoassay, Phencyclidine 1Reagent, Coronavirus Serological 1Kit, Test, Multiple, Drugs Of Abuse, Over The Counter 1Kit, Test, Pregnancy, Hcg, Over The Counter 1Visual, Pregnancy Hcg, Prescription Use 1Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Enzyme Immunoassay, Amphetamine 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K181945	QuickScreen Pro Multi Drug Screening Test, Model 9395Z	2018-10-18
US	K131069	QUICKSCREEN AMPHETINE 500 TEST	2014-05-14
US	K103295	QUICKSCREEN COCAINE 150 SCREENING TEST	2012-02-01
CA	73428	CLEAR CHOICE AT HOME PREGNANCY TEST	Class II

Phamatech, 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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