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Radiometer Medical A/S

Denmark · Bronshoj
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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
0valid device licences
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 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
Same-named companies — This database also contains companies with near-identical names: RADIOMETER MEDICAL APS, Radiometer Medicals Aps. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Denmark
City
Bronshoj

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

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)

MarketIdentifierNameClass / date
USK252488ABL90 FLEX PLUS System2026-05-01
USK252475ABL90 FLEX PLUS System2026-05-01
USK252207ABL90 FLEX PLUS System, safeCLINITUBES2026-04-10
BR10301160122S5362 Hypochlorite Solution - REF: 943-906 (para analisadores de gasesClass I
BR10301160222Range+ Qualicheck Level 2 S7940, REF: 944-152Class II
BR10301160223Range+ QUALICHECKClass II
SAME0000002567SFDAA00197TCM5 Alice Int Interface Cable—
SAME0000002567SFDAA00198Tc Sensor 54 Membraning kit 54—
CA10216CMT10Class II
CA10219FLM3Class II
CA10224ABL30Class II

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