Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010312

FEI Number

3008237808

Entity Name

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

City/State/Country

Rome Roma, IT

Establishment Address

Via Zosimo 13 - 00178 Rome - Italy, Via Angela Vacchi 23/25 - 04011 Aprilia (LT) - Italy, Rome Roma 00178, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

H.S. HOSPITAL SERVICE S.P.A. (Owner Number: 8010312)

Owner / Operator Contact Address

Via Zosimo 13 - 00178 Rome - Italy, Via Angela Vacchi 23/25 - 04011 Aprilia (LT) - Italy, ROMA, IT-62 00178, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K013692

PMA Number

N/A

All Registered Proprietary Names

HS AMICA HS AMICA ECOJEKT MB SET PEIT NEEDLE INTRODUCER NEEDLE BIOMOL ALM SET PRECISA HS AMICA BMN I TYPE BMN J TYPE HARVEST NEEDLE TRAPSYSTEM SET

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2010-01-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-02-12
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2002-05-30
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2008-03-14
MIJ	Needle, Tumor Localization	General, Plastic Surgery	Class 1	878.4800	2010-01-29
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2008-03-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-09-14
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2004-12-08
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2008-07-16
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2008-07-16
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2008-03-14

Official Correspondent

No official correspondent registered.

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

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

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0210-2022	Covidien Llc	2	Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

Similar Registrations

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3008132398	Sterigenics UK Limited	Alfreton Derbyshire, GB
3022977243	Varian Medical Systems, Inc.	Shoreview, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010312. Last updated year: 2026. Please use registration number 8010312 when referencing this establishment in official correspondence.