Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006849754

FEI Number

3006849754

Entity Name

STERIL VERONA s.r.l.

City/State/Country

ERBE Verona, IT

Establishment Address

Via San Giuseppe, 30/31, ERBE Verona 37060, 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

Centrifugal Blood Pump CP22 Citieffe External Fixator ST.A.R. 90 F4 ELBOW Citieffe External Fixator ST.A.R. 90 F4 KNEE ST.A.R. 90 F4 External Fixato ESTREMO CITIEFFE NAILING SYSTEM Re-Infusion Line SP-394 Accessory Extension Line SP-420 Accessory Spike SP-C13 3004-02 3002-01 3003-01 3002-02 3001-02 3004-01 3001-01 OAF002012, OAF703612, OAF702703, OAF702793, OAF703603, OAF703613, OAF703693 "OAF009912, OAF008012, OAF005512, OAF002712, OAF402012, OAF402712 " OAF002003, OAF002013, OAF002703, OAF002713, OAF003603, OAF003613, OAF005503, OAF005513, OAF006003, OAF006013, OAF008003 OAF102713, OAF102793, OAF103613, OAF103693, PROSTHESIS FOR OTOSURGERY 4017-N2 4012-N5 4013-N6 4017-N4 Dolphix® External Fixation System MR Conditional DOLPHIX® EX.FIX.SYS. MR CONDITIONAL Patellar Component EMP-FBX200BHS-C EMP-FBX200BHS Accessory "Y" Connector S-660-C Gambro G Series Blood Line Sets GMB-SP127 Y Connector 4013-08 4012-01 4013-12 4013-13 4017-04 4013-15 4017-03 4013-11 4013-14 4017-01 4013-16 4017-02 4012-05 4013-10 Centrifugal Blood Pump CP22 with Integrated Sensors DOLPHIX® EXTERNAL FIXATION SYSTEM Dolphix External Fixation System Carpediem - preassembled disposable device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2026-03-20
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2026-03-19
FAP	Cystometric Gas (Carbon-Dioxide) On Hydraulic Device	Gastroenterology, Urology	Class 2	876.1620	2026-03-19
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2026-03-19
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-02-26
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2013-02-26
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2026-03-19
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2026-03-18
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2013-02-26
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2026-03-19
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2026-03-19
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2026-03-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-03-20
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2026-03-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-03-18
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2026-03-06
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2026-03-06
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2026-06-04
ONO	Neurosurgical Laser With Mr Thermography	General, Plastic Surgery	Class 2	878.4810	2026-03-19
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2013-02-26
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2026-03-18
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2026-03-18
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2026-03-18
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2023-03-23
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2026-03-19
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2026-03-19
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2026-03-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-02-26
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2013-02-26
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2026-03-19
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2022-07-14
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2026-03-18
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2026-03-18
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2026-03-19
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2026-03-19
QIR	Pediatric Hemodialysis System	Gastroenterology, Urology	Class 2	876.5861	2026-05-28

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
3011554160	Steril Verona srl	Nogara Verona, IT
3015136750	Steril Verona srl	Trevenzuolo Verona, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033504	General Electric Co.	GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM	2003-11-25
K013636	GE Medical Systems	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY	2002-01-24
K250443	Siemens Healthcare GmbH	MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile	2025-06-16
K151015	Hitachi Medical Systems America, Inc.	ECHELON Oval V 5.0 MRI System	2015-07-29
K910715	Philips Medical Systems (Cleveland), Inc.	VISTA HPQ SYSTEM	1991-06-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2007	Hitachi Medical Systems America Inc	2	MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014	Philips Medical Systems (Cleveland) Inc	2	Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Z-0389-2024	Philips North America Llc	2	Achieva 1.5T
Z-0390-2024	Philips North America Llc	2	Achieva 1.5T Conversion
Z-0391-2024	Philips North America Llc	2	Achieva 1.5T Initial System

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006849754. Last updated year: 2026. Please use registration number 3006849754 when referencing this establishment in official correspondence.