STEROX SRL

FDA Device Registration & Listing · Filago Bergamo, IT · Registration 3030125051

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3030125051
FEI Number
3030125051
Entity Name
STEROX SRL
City/State/Country
Filago Bergamo, IT
Establishment Address
Via delle Industrie, 9, Filago Bergamo 24040, IT
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
STEROX SRL (Owner Number: 10084103)
Owner / Operator Contact Address
via galvani 9/G, Spresiano, IT-TV 31027, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Spectrum Medical S.r.l. Spectrum Medical S.r.l. Spectrum Medical S.r.l. Spectrum Medical S.r.l. RAND S.p.A. Spectrum Medical S.r.l. Spectrum Medical S.r.l. Spectrum Medical S.r.l. Spectrum Medical S.r.l. Spectrum Medical S.r.l. BiBBInstruments AB Eurosirel S.p.A. Spectrum Medical S.r.l. Spectrum Medical S.r.l. WISE SpA Spectrum Medical S.r.l. RAND S.p.A. Spectrum Medical S.r.l. Spectrum Medical Spectrum Medical S.r.l.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2025-09-22
DTR Heat-Exchanger, Cardiopulmonary Bypass Cardiovascular Class 2 870.4240 2025-09-22
DTR Heat-Exchanger, Cardiopulmonary Bypass Cardiovascular Class 2 870.4240 2025-09-22
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2025-09-22
LGZ Warmer, Thermal, Infusion Fluid General Hospital Class 2 880.5725 2023-12-18
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2025-09-22
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2025-09-22
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2026-02-13
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2025-09-22
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2025-09-22
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2026-01-07
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2025-03-10
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2025-09-22
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2025-09-22
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2026-03-16
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2025-09-22
LGZ Warmer, Thermal, Infusion Fluid General Hospital Class 2 880.5725 2023-12-18
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2025-09-22
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2025-09-22
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2025-09-22

Official Correspondent

Mario Pavan

US Agent Details

Caterina Zimmerman Business: Pangea Export USA LLC Email: info@pangeaexport.us Phone: (415) 2506061

Related Public Records

Same Entity

STEROX SRL
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3021566676 STEROX SRL Castelfranco Piandisco Arezzo, IT

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K832124 Med-West, Inc. CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI 1983-08-12
K162500 Spyder Medical Ostial Sprit Cannulae 2017-01-12
K862357 3M Health Care, Sarns MODIFIED CARDIOTOMY RESERVOIR 5M1470 1986-08-19
K150891 Covidien, LLC( Formerly Beacon Endoscopic Corp.) BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System 2015-05-01
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2022 Medtronic Perfusion Systems 2
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018 OriGen Biomedical, Inc. 2
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
Z-0029-2012 Olympus America Inc. 2
OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

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3009380063 Medtronic Distribution Center Memphis, TN, US
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1836324 Rose Medical Grand Rapids, MI, US
3019807891 CENTERPIECE S. DE R.L DE C.V (sterilization site) Tijuana Baja California, MX
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030125051. Last updated year: 2026. Please use registration number 3030125051 when referencing this establishment in official correspondence.
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