HomeItalySTEELCO S.P.A.

STEELCO S.P.A.

Italy · Riese Pio X
✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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 3Class II 2Class III 0
plus 5 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
8registered devices
Class I 1Class II 7
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
0active device licences
8 including historic records
TWTaiwanTFDA
7valid device licences
Class I 2Class II 5
SGSingaporeHSA SMDR
8device registrations
CLASS B 3CLASS C 5
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Business type not stated 1
AUAustraliaTGA ARTG
10active ARTG entries
Class I 5IIb 5
HKHong KongMDACS
2valid listings
Class III 2
ILIsraelAMAR
11registrations
RURussiaRoszdravnadzor
20active registrations
Class 1 3Class 2a 17
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 States5 registration records, 1 510(k), 0 PMA
Brazil8 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: STEELCO S.P.A. · STEELCO S.P.A · Steelco SPA

Company information

Country
Italy
City
Riese Pio X

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

12023 · K213545

FDA listed device types

Cleaner, Ultrasonic, Medical Instrument 1Washer Of Body Waste Receptacles 1Unit, Drying 1Sterilizer, Steam 1Disinfector, Medical Devices 1

Registration details (sample)

MarketIdentifierNameClass / date
USK213545Steelco VS Series Steam Sterilizers, models 262839, 262851, 2628692023-02-02
BR81491649001Lavadora Termodesinfetadora STEELCOClass II
BR81178350015ESTERILIZADORA A BAIXA TEMPERATURA POR VAPOR DE PERÓXIDO DE HIDROGÊNIOClass II
BR81178350018ESTERILIZADOR VS STEELCOClass II
SAME0000004129SFDAA00002ULTRASONIC CLEANING SYSTEM

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