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Advin Biotech, Inc.

USA · San Diego CA · www.advinbio.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

39listed device types

Class I 3Class II 32Class III 0unclassified 4

plus 23 registration records and 4 510(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 States23 registration records, 4 510(k), 0 PMA

Manufacturer names merged into this page: ADVIN BIOTECH, INC.

FDA 510(k) clearances by year

12013 · K122809

12019 · K182123

12020 · K201494

12025 · K252867

FDA listed device types

showing 8 of 39

Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt 1Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Test, Propoxyphene, Over The Counter 1Thin Layer Chromatography, Methamphetamine 1Test, Benzodiazepine, Over The Counter 1Test, Tricyclic Antidepressants, Over The Counter 1Test, Methadone, Employment And Insurance Testing, Exempt 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252867	VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup	2025-10-09
US	K201494	ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card	2020-09-17
US	K182123	ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card	2019-03-29

Advin Biotech, 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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