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Streck, Inc.

USA · La Vista

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Hong Kong, 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 3Class II 16Class III 0

plus 57 registration records and 38 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class 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

35active device licences

Class II 32Class III 3

55 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

15device registrations

CLASS B 15

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

2valid listings

IVD C 2

ILIsraelAMAR

7registrations

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 States57 registration records, 38 510(k), 0 PMA, 1 excluded

Brazil2 confirmed, 1 excluded

Canada35 confirmed, 0 excluded

Manufacturer names merged into this page: STRECK LLC · STRECK

FDA 510(k) clearances by year

22005

32006

12007

22008

42009

12010

32011

42012

52014

42016

12017

12020

12022

22023

12024

32026

FDA listed device types

showing 8 of 19

Control, Cell Counter, Normal And Abnormal 1Counter, Differential Cell 1Tubes, Vacuum Sample, With Anticoagulant 1Test, Sickle Cell 1Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays 1Calibrator For Platelet Counting 1Material, Quality Control, Semen Analysis 1Calibrator For Red-Cell And White-Cell Counting 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260041	MDx-Chex for BCP	2026-03-27
US	K254166	MDx-Chex for BCN	2026-03-23
US	K254167	MDx-Chex for BCY	2026-03-17
BR	80117580771	Família de Tubos de Coleta de Sangue	Class I
BR	81692610029	Família de Calibradores Hematológico Streck - Hemogram	Class II
CA	9179	CHEM-CHEX BLOOD GAS	Class III
CA	9180	CHEM-CHEX MULTI-ANALYTE	Class II
CA	8478	PARA 4	Class II

Streck, 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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