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H.S. HOSPITAL SERVICE S.P.A.

Italy · Rome Roma

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Singapore — 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

6listed device types

Class I 2Class II 4Class III 0

plus 14 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class II 9

10 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States14 registration records, 16 510(k), 0 PMA, 79 excluded

Brazil9 confirmed, 14 excluded

Saudi Arabia0 confirmed, 7 excluded

Canada0 confirmed, 8 excluded

Manufacturer names merged into this page: H.S. HOSPITAL SERVICE S.P.A.

Same-named companies — This database also contains companies with near-identical names: H.S. Hospital Service S.R.L., H.S. Hospital Services S.P.A.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

32000

32001

32002

12004

12009

12014

12015

12019

22024

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1System, Ablation, Microwave And Accessories 1Instrument, Biopsy 1Biopsy Needle 1Needle, Aspiration And Injection, Disposable 1Needle, Tumor Localization 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242029	TRAP EASY	2024-10-09
US	K232072	AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G	2024-02-09
US	K182605	HS AMICA devices family	2019-10-28
BR	80102519354	ABS	Class II
BR	80102519355	TRAPSYSTEM SET	Class II
BR	80102519356	HS NOTA COM AGULHA INTRODUTORA	Class II

H.S. HOSPITAL SERVICE S.P.A.

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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