Steril Verona srl

FDA Device Registration & Listing · Trevenzuolo Verona, IT · Registration 3015136750

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
3015136750
FEI Number
3015136750
Entity Name
Steril Verona srl
City/State/Country
Trevenzuolo Verona, IT
Establishment Address
Via del Lavoro 25, Trevenzuolo 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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SEMICUT Semiautomatic guillotine needle XXGxYYYmm for soft tissues biopsy without removable Lu EASYCUT Semiautomatic needle XXGxYYYmm for cytohistological biopsy by aspiration as for Mengh THEMY Automatic needle XXGxYYYmm for soft tissue biopsy. Notch 20mm PALIUM NEEDLE Guillotine needle XXGxYYYmm soft tissue biopsy, Magnum Gun Bard and Palium Palium Automatic reusable gun for soft tissue biopsy INTRO Coaxial introducer needle XXG for needles XXG Purema H Hemoconcentrator (EtO sterilized) HPH Junior - High Performance Hemoconcentrator HydraGuard 10" UltraFilter; HydraGuard 10" UltraFilter Flush; HydraGuard 20" UltraFilter DSU-H Ultrafilter; SSU-H Ultrafilter Hemocor HP Hemoconcentrator - HP700 + TS DSU D DSU-D; MSU; SSU Mini JG; SSU Mini; SSU-D Vitasmart Kit EndoPur Endotoxin 10" Filter; EndoPur Endotoxin 20" Filter Renaflo II Hemofilter - 400-700-1200 H2H Infusion Set; H2H Rinse Line; H2H Substitution Filter; H2H Water Filter; Nephros On-Line Mid-Dilution Hemodiafiltrat Hemocor HP Hemoconcentrators - 400-1000-1400 + TS S100 In-Line; S100 Shower Handheld; S100 Sink Spout; S100 Sink Spray

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2024-01-23
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2024-01-23
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2026-05-28
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2026-05-28
NHV System, Water Purification, General Medical Use Gastroenterology, Urology Class 2 876.5665 2026-05-28
NHV System, Water Purification, General Medical Use Gastroenterology, Urology Class 2 876.5665 2026-05-28
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2026-05-28
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2026-05-28
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2026-05-28
SGY Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant Gastroenterology, Urology Class 2 876.5881 2026-05-28
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2026-05-28
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2026-05-28
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2026-05-28
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2026-05-28
NHV System, Water Purification, General Medical Use Gastroenterology, Urology Class 2 876.5665 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
3006849754 STERIL VERONA s.r.l. ERBE Verona, IT

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K172344 Medax Srl Unipersonale Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) 2017-11-13
K150891 Covidien, LLC( Formerly Beacon Endoscopic Corp.) BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System 2015-05-01
K811830 Cordis Corp. C-DAK DUO-FLUX ARTIFICIAL KIDNEY 1981-09-21
K070320 Edwards Lifesciences Services GmbH EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 2007-06-07
K150880 Outset Medical Tablo Console with Wireless Capability 2015-05-01

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2024 Bard Peripheral Vascular Inc 2
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Z-0028-2013 Remington Medical Inc. 2
Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
Z-0042-2014 Atossa Genetics, Inc. 2
Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
Z-0044-2018 Bard Peripheral Vascular Inc 2
BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015136750. Last updated year: 2026. Please use registration number 3015136750 when referencing this establishment in official correspondence.
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