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COSMED S.R.L.

Italy · Albano Laziale

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Hong Kong, Israel, Russia — 8 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

7listed device types

Class I 0Class II 7Class III 0

plus 10 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 2Class II 6

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

3active device licences

Class II 3

17 including historic records

TWTaiwanTFDA

9valid device licences

Class II 9

SGSingaporeHSA SMDR

11device registrations

CLASS B 11

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 4

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 States10 registration records, 0 510(k), 0 PMA, 3 excluded

Brazil8 confirmed, 1 excluded

Canada3 confirmed, 1 excluded

Manufacturer names merged into this page: COSMED S.R.L.

FDA listed device types

Calculator, Pulmonary Function Data 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Spirometer, Diagnostic 1Calculator, Predicted Values, Pulmonary Function 1Oximeter 1Ventilator, Continuous, Facility Use 1Computer, Oxygen-Uptake 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80181930021	CARROS METABOLICOS PORTATEIS	Class II
BR	80975359002	MicroQuark	Class II
BR	80181939004	FILTRO ANTIBACTERIANO	Class II
CA	77247	K4B2	Class II
CA	77250	PONY FX FLOWSAFE	Class II
CA	78234	SPIROPALM PLUS HAND HELD SPIROMETER	Class II

COSMED S.R.L.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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