Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012708860

FEI Number

3012708860

Entity Name

STERIS Italy S.r.l.

City/State/Country

Pomezia Roma, IT

Establishment Address

Via Laurentina, 169, Pomezia Roma 00071, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

STERIS Corporation (Owner Number: 2150060)

Owner / Operator Contact Address

5960 Heisley Rd, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Compensated single articulation headrest (HEAD02) (MG-SD, LC-FE, PM-CM) Table Clamp (BF788, TAB841) (MG-SD, LC- FE, PM-CM) CLEANASCOPE Liners (PM-SD) CLEANASCOPE Advantage Cart Catheter Extension (BF789, BF794, TAB800KT) (MG-SD, LC-FE, PM-CM) CMAX XRAY NA JOYSTICK (BF714, TAB800JSNA) (MG-SD, LC-FE, PM-CM) ENDODRY Storage & Drying System (PM-MF) Tubing Sets for Reliance 6500 Series Endoscope Drying and Storage Cabinet (PY-SD, HP-MF) Cassette Tray and Film Holder (TAB733) (MG-SD, LC-FE, PM-CM)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HBM	Headrest, Neurosurgical	Neurology	Class 1	882.4440	2025-03-09
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2025-03-09
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2015-10-16
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2025-03-09
PUP	Endoscope Maintenance System	Gastroenterology, Urology	Class 2	876.1500	2024-04-04
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2025-03-09

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: STERIS Corporation Email: becky_aldhizer@steris.com Phone: (440) 4687462

Related Public Records

Same Entity

STERIS Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018811167	MEDIVATORS INC	Rogers, MN, US
3038285067	Synergy Sterilisation Kulim (M) Sdn. Bhd	Seberang Perai Selatan Pulau Pinang, MY
3031571464	Herotron E-Beam Service GmbH	Bitterfeld Saxony-Anhalt, DE
3010897183	Synergy Health Marseille SAS	CHUSCLAN Gard, FR
3008252486	ELECTRON BEAM SDN BHD	Port Klang Selangor, MY

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2024	Getinge Usa Sales Inc	1	Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012708860. Last updated year: 2026. Please use registration number 3012708860 when referencing this establishment in official correspondence.