HomeUSAH.S. Hospital Service S.R.L.

H.S. Hospital Service S.R.L.

USA · South Glastonbury
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Israel — 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
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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.P.A., H.S. Hospital Services S.P.A.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
South Glastonbury

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

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)

MarketIdentifierNameClass / date
USK242029TRAP EASY2024-10-09
USK232072AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G2024-02-09
USK182605HS AMICA devices family2019-10-28
BR80102519354ABSClass II
BR80102519355TRAPSYSTEM SETClass II
BR80102519356HS NOTA COM AGULHA INTRODUTORAClass II

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