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RADIOMETER AMERICA, INC.

USA · Middleburg Heights

✓ 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

2listed device types

Class I 2Class II 0Class III 0

plus 2 registration records and 50 510(k), 4 PMA

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 States2 registration records, 50 510(k), 4 PMA, 10 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: RADIOMETER AMERICA, INC.

FDA 510(k) clearances by year

21983

21984

11985

11986

11987

51989

41990

11991

51992

21993

51994

81995

51996

11997

31998

21999

12000

12016

FDA listed device types

Multi-Analyte Controls, All Kinds (Assayed) 1Arterial Blood Sampling Kit 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K153712	VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit	2016-01-28
US	K992859	ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE	2000-01-10
US	K991417	ABL 735 ANALYZER	1999-11-24

RADIOMETER AMERICA, 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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