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UCP Biosciences Inc.

USA · Milpitas CA · www.ucpbiosciences.com

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

0UDI-DI device records

USUnited StatesFDA openFDA

14listed device types

Class I 1Class II 12Class III 0unclassified 1

plus 13 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

0registered device records

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

TWTaiwanTFDA

pendingnot queried

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 States13 registration records, 14 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: UCP BIOSCIENCES, INC.

FDA 510(k) clearances by year

12005

12006

12007

12009

12010

12011

12012

42013

12014

12015

12016

FDA listed device types

showing 8 of 14

Enzyme Immunoassay, Opiates 1Radioimmunoassay, Tricyclic Antidepressant Drugs 1Enzyme Immunoassay, Benzodiazepine 1Enzyme Immunoassay, Amphetamine 1Enzyme Immunoassay, Methadone 1Gas Chromatography, Methamphetamine 1Thin Layer Chromatography, Methamphetamine 1Enzyme Immunoassay, Propoxyphene 1

Market	Identifier	Name	Class / date
US	K152908	UCP COMPACT DRUG TESTS	2016-05-03
US	K151213	UCP Drug Test Mini Cups	2015-08-21
US	K132812	UCP MULTI-DRUG TEST KEY CUPS	2014-03-06

UCP Biosciences 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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