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VERICHEM LABORATORIES, INC.

USA · Providence

✓ 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

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 1Class II 4Class III 0

plus 9 registration records and 14 510(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

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 States9 registration records, 14 510(k), 0 PMA

Manufacturer names merged into this page: VERICHEM LABORATORIES, INC.

FDA 510(k) clearances by year

71988 · K882059

11990 · K901113

11991 · K912513

11993 · K924904

31997 · K974290

12012 · K112834

FDA listed device types

Calibrator, Multi-Analyte Mixture 1Calibrator, Secondary 1Calibrator, Primary 1Calibrators, Ethyl Alcohol 1Enzyme Controls (Assayed And Unassayed) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K112834	MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES	2012-03-28
US	K974290	MICROPROTEIN STANDARD KIT	1997-12-19
US	K973345	MATRIX PLUS MULTI-CALIBRATOR KIT	1997-10-29

VERICHEM LABORATORIES, 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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