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CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH

Germany · Grafelfing

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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 14Class II 5Class III 0

plus 19 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

69registered devices

Class I 5Class II 64

90 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

25active device licences

Class II 25

78 including historic records

TWTaiwanTFDA

16valid device licences

Class I 13Class II 3

SGSingaporeHSA SMDR

9device registrations

CLASS B 6CLASS C 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

6active ARTG entries

IVD Class 2 5IVD Class 3 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 1Class 2b 1

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 States19 registration records, 1 510(k), 0 PMA

Brazil69 confirmed, 0 excluded

Canada25 confirmed, 0 excluded

Manufacturer names merged into this page: CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH

FDA 510(k) clearances by year

12009 · K080459

FDA listed device types

showing 8 of 19

Calibrators, Ethyl Alcohol 1Calibrator, Secondary 1Calibrator, Multi-Analyte Mixture 1Calibrators, Drug Specific 1Enzyme Immunoassay, Tracrolimus 1Acid, Trifluoroacetic, Vitamin A, Hexane Extraction 1Urinalysis Controls (Assayed And Unassayed) 1Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K080459	CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS	2009-11-17
BR	10350840119	VITAMINAS A/E NO SORO OU PLASMA (HPLC)	Class II
BR	10350840118	DROGAS ANTI EPILETICAS NO SORO OU PLASMA (HPLC)	Class II
BR	10350840116	BENZODIAZEPÍNICOS E ANTIDEPRESSIVOS TRICÍCLICOS	Class II
CA	73751	REAGENT KIT FOR THE HPLC-ANALYSIS OF ANTI-HIV DRUGS IN PLASMA/SERUM	Class II
CA	73756	REAGENT KIT FOR THE HPLC-ANALYSIS OF CROSSLINKS IN URINE	Class II
CA	73804	REAGENT KIT FOR THE HPLC-ANALYSIS OF CDT IN SERUM	Class II

CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH

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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