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Dba Systems, Inc.

USA · Washington

✓ 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

41listed device types

Class I 18Class II 23Class III 0

plus 38 registration records and 19 510(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

9active device licences

Class II 9

45 including historic records

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 States38 registration records, 19 510(k), 0 PMA, 305 excluded

Brazil0 confirmed, 43 excluded

Saudi Arabia0 confirmed, 14 excluded

Canada9 confirmed, 142 excluded

Manufacturer names merged into this page: Infrared Laboratory Systems dba SYNERMED · INFRARED LABORATORY SYSTEMS LLC DBA SYNERMED INTERNATIONAL, INC. · SRS MEDICAL SYSTEMS, INC. DBA FASSTECH · TACTILE SYSTEMS TECHNOLOGY, INC. (DBA TACTILE MEDICAL) · VYGON US DBA VYGON CORPORATION, DBA CHURCHILL MEDICAL SYSTEMS

FDA 510(k) clearances by year

11994

12000

12010

12012

12013

22016

42017

22018

22019

12020

22021

12022

FDA listed device types

showing 8 of 41

System, Test, Sodium, Enzymatic Method 1Alkaline Picrate, Colorimetry, Creatinine 1Calibrator, Secondary 1Electrode, Ion-Specific, Chloride 1Test, System, Potassium, Enzymatic Method 1Catalytic Methods, Amylase 1Biuret (Colorimetric), Total Protein 1Calibrators, Drug Mixture 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K214045	FreedomEdge Syringe Infusion System	2022-04-29
US	K200176	FREEDOM Integrated Syringe Infusion System	2021-12-15
US	K211206	FreedomEdge(R) Syringe Infusion System	2021-11-09
CA	71731	IR CAL II	Class II
CA	71732	BILIRUBIN REAGENT	Class II
CA	71733	CREATININE REAGENTS	Class II

Dba Systems, 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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