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INTERSURGICAL S.P.A.

Italy · Mirandola (Mo)

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Russia — 5 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

3listed device types

Class I 3Class II 0Class III 0

plus 3 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 1Class II 3

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

5active device licences

Class II 5

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 States3 registration records, 0 510(k), 0 PMA, 9 excluded

Brazil4 confirmed, 3 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada5 confirmed, 2 excluded

Manufacturer names merged into this page: INTERSURGICAL S.P.A.

Registration details (sample)

Market	Identifier	Name	Class / date
BR	82737659092	Capacete para VNI CaStar	Class II
BR	82737659093	Máscara Ventumask para CPAP	Class II
BR	82737659094	Capacete CaStar para CPAP	Class II
CA	68154	CASTAR HOODS FOR CPAP AND/OR NIV	Class II
CA	68283	STARBALL CPAP RESERVOIR	Class II
CA	68284	PEEP VALVES	Class II

INTERSURGICAL S.P.A.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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