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DIMA ITALIA SRL

Italy · Bologna Bologna

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Taiwan, Australia, Israel, 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 1Class II 2Class III 0

plus 4 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

0active device licences

TWTaiwanTFDA

7valid device licences

Class II 7

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 2IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 3Class 2b 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 States4 registration records, 4 510(k), 0 PMA

Brazil0 confirmed, 1 excluded

Manufacturer names merged into this page: DIMA ITALIA SRL

FDA 510(k) clearances by year

22008 · K072290

22014 · K140598

FDA listed device types

Set, Tubing And Support, Ventilator (W Harness) 1Device, Positive Pressure Breathing, Intermittent 1Ventilator, External Body, Negative Pressure, Adult (Cuirass) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K140598	PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC	2014-10-16
US	K140605	MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC	2014-10-03
US	K072290	PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS	2008-05-29

DIMA ITALIA SRL

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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