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RADIOMETER BASEL AG

Switzerland · Basel

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Canada, Israel — 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

5listed device types

Class I 0Class II 5Class III 0

plus 1 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States1 registration records, 1 510(k), 0 PMA

Saudi Arabia1 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: RADIOMETER BASEL AG · Radiometer Basel AG

FDA 510(k) clearances by year

12007 · K063434

FDA listed device types

Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia 1Oximeter, Ear 1Monitor, Carbon-Dioxide, Cutaneous 1Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia 1Oximeter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K063434	TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM	2007-01-22
SA	ME0000002568SFDAA00001	TCM5 Calibration Gas	—
CA	16881	PO2 SENSOR	Class II
CA	16882	PCO2 SENSOR	Class II
CA	16884	COMBI SENSOR	Class II

RADIOMETER BASEL AG

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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