Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011554160

FEI Number

3011554160

Entity Name

Steril Verona srl

City/State/Country

Nogara Verona, IT

Establishment Address

Via Fontana 2, Nogara Verona 37054, IT

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

STERIL VERONA s.r.l. (Owner Number: 10023713)

Owner / Operator Contact Address

Via San Giuseppe, 31, ERBE', IT-VR 37060, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2014-03-25
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2017-01-26
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2014-03-25
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2014-03-18
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2014-03-25
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2014-03-18
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2013-03-02
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2014-03-25
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2014-03-18
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2014-03-25
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2014-03-17
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2014-03-25
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2014-03-25
DTP	Defoamer, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4230	2014-03-17
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2014-03-17
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2013-08-26
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2014-03-17
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2014-03-25
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2014-03-17
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2017-01-26
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2014-03-25
FXT	Film, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2013-03-02
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2014-03-18
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2014-03-25
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2013-08-26
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2014-03-25
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2014-03-17
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2014-03-18
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2017-01-26
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2017-11-03
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2014-03-17
DTP	Defoamer, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4230	2017-01-26
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2014-03-17
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2014-03-17
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2014-03-25
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2014-03-18
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2014-03-18
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2014-03-18
DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4420	2014-03-25
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2013-08-26
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2017-01-26
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2014-03-17
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2014-03-25
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2013-03-11
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2014-03-17
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2013-08-26
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2014-03-18
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2016-07-21
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2014-03-18
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2014-03-18
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2014-03-25
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2014-03-25
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2014-03-25
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2014-03-17
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2014-03-25
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2014-03-25
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2014-03-17
DQR	Cannula, Catheter	Cardiovascular	Class 2	870.1300	2014-03-25
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2014-03-18
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2014-03-17
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2014-03-25
DTP	Defoamer, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4230	2014-03-17
JOD	Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4270	2014-03-17
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2014-03-17
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2014-03-25
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4220	2014-03-17
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2014-04-30
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2017-01-26
DTP	Defoamer, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4230	2017-01-26
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2017-11-03
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2014-03-17
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2014-03-25
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2014-03-17
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2014-03-17
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2014-03-25
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2014-03-18
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2014-03-18
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2013-03-02
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2013-03-02
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2013-03-02
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2013-03-02
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2019-11-29
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2019-11-29

Official Correspondent

Ottavio De Santi

US Agent Details

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

Related Public Records

Same Entity

STERIL VERONA s.r.l.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015136750	Steril Verona srl	Trevenzuolo Verona, IT
3006849754	STERIL VERONA s.r.l.	ERBE Verona, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914791	Gish Biomedical, Inc.	GISH ARTERIAL FILTER	1993-04-06
K790435	Surgikos, Inc.	*INTERSEPT BLOOD FILTER W/ TUBING BYPASS**	1979-03-27
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04
K862357	3M Health Care, Sarns	MODIFIED CARDIOTOMY RESERVOIR 5M1470	1986-08-19

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-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0001-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0002-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Similar Registrations

Registration Number	Establishment Name	Location
1928237	MIDWEST STERILIZATION CORP.	JACKSON, MO, US
1643817	ISOMEDIX OPERATIONS INC	EL PASO, TX, US
2184009	MEDTRONIC PERFUSION SYSTEMS	Minneapolis, MN, US
8010026	TERUMO CORP.	SHIBUYA-KU, TOKYO, JP
8010762	MAQUET CARDIOPULMONARY GmbH	Hechingen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011554160. Last updated year: 2026. Please use registration number 3011554160 when referencing this establishment in official correspondence.