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Asensus Surgical Italia, S.r.l.

Italy · Milano Lombardy

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, Russia — 3 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

4listed device types

Class I 1Class II 3Class III 0

plus 37 registration records and 6 510(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

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 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 States37 registration records, 6 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: Asensus Surgical Italia, S.r.l. · Asensus Surgical, Inc.

FDA 510(k) clearances by year

22021 · K212054

12022 · K220889

12023 · K223095

12024 · K233866

12026 · K254192

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Laparoscope, General & Plastic Surgery 1System, Surgical, Computer Controlled Instrument 1Camera, Television, Endoscopic, With Audio 1

Market	Identifier	Name	Class / date
US	K254192	Senhance Ultrasonic System	2026-05-12
US	K233866	Senhance Surgical System	2024-07-19
US	K223095	Senhance Surgical System	2023-03-16

Asensus Surgical Italia, S.r.l.

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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