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RADIOMETER MEDICAL APS

Denmark · Bronshoj

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

26listed device types

Class I 6Class II 20Class III 0

plus 23 registration records and 35 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

35registered devices

Class I 9Class II 26

70 including historic records

SASaudi ArabiaSFDA

27registered imported devices

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

CACanadaMDALL

22active device licences

Class II 21Class III 1

47 including historic records

TWTaiwanTFDA

20valid device licences

Class I 5Class II 15

SGSingaporeHSA SMDR

15device registrations

CLASS B 4CLASS C 11

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

21active ARTG entries

Class I 6IVD Class 1 4IVD Class 2 5IVD Class 3 2IIa 2IIb 2

HKHong KongMDACS

13valid listings

Class II 5Class III 2IVD C 6

ILIsraelAMAR

11registrations

RURussiaRoszdravnadzor

15active registrations

Class 1 5Class 2a 7Class 2b 3

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 States23 registration records, 35 510(k), 0 PMA, 8 excluded

Brazil35 confirmed, 0 excluded

Saudi Arabia27 confirmed, 1 excluded

Canada22 confirmed, 1 excluded

Manufacturer names merged into this page: RADIOMETER MEDICAL APS · Radiometer Medical ApS

FDA 510(k) clearances by year

22000

12004

52005

12006

32010

22011

52012

52013

12014

22015

12016

22017

12024

12025

32026

FDA listed device types

showing 8 of 26

Acid, Lactic, Enzymatic Method 1Bilirubin (Total And Unbound) In The Neonate Test System 1Tube, Collection, Capillary Blood 1Controls For Blood-Gases, (Assayed And Unassayed) 1Multi-Analyte Controls, All Kinds (Assayed) 1Medical Device Data System 1System, Hemoglobin, Automated 1Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252488	ABL90 FLEX PLUS System	2026-05-01
US	K252475	ABL90 FLEX PLUS System	2026-05-01
US	K252207	ABL90 FLEX PLUS System, safeCLINITUBES	2026-04-10
BR	10301160122	S5362 Hypochlorite Solution - REF: 943-906 (para analisadores de gases	Class I
BR	10301160222	Range+ Qualicheck Level 2 S7940, REF: 944-152	Class II
BR	10301160223	Range+ QUALICHECK	Class II
SA	ME0000002567SFDAA00197	TCM5 Alice Int Interface Cable	—
SA	ME0000002567SFDAA00198	Tc Sensor 54 Membraning kit 54	—
CA	10216	CMT10	Class II
CA	10219	FLM3	Class II
CA	10224	ABL30	Class II