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LIN-ZHI INTERNATIONAL, INC.

USA · Santa Clara

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel — 7 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 4Class II 14Class III 0unclassified 1

plus 41 registration records and 50 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

55active device licences

Class II 55

65 including historic records

TWTaiwanTFDA

5valid device licences

Class II 5

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 2 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States41 registration records, 50 510(k), 0 PMA, 6 excluded

Brazil1 confirmed, 0 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada55 confirmed, 0 excluded

Manufacturer names merged into this page: LIN-ZHI INTERNATIONAL, INC.

FDA 510(k) clearances by year

92002

62003

22004

22005

52006

12008

12009

22010

32011

32012

42014

22015

12017

22018

22019

32020

12025

12026

FDA listed device types

showing 8 of 19

Calibrators, Ethyl Alcohol 1Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Calibrators, Drug Mixture 1Enzyme Immunoassay, Amphetamine 1Enzyme Immunoassay, Methadone 1Gas Chromatography, Methamphetamine 1Calibrators, Drug Specific 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253082	LZI Buprenorphine II Enzyme Immunoassay	2026-01-16
US	K251634	LZI Fentanyl III Enzyme Immunoassay	2025-06-18
US	K202007	LZI Oxycodone III Enzyme Immunoassay	2020-09-17
BR	10287411553	Família EDDP	Class II
CA	75358	METHADONE METABOLITE ENZYME IMMUNOASSAY	Class II
CA	76295	BUPRENORPHINE ENZYME IMMUNOASSAY	Class II
CA	79978	NORBUPRENORPHINE CALIBRATORS	Class II

LIN-ZHI INTERNATIONAL, 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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