STERIS AST CZ s.r.o.

FDA Device Registration & Listing · VELKA BITES Vysocina, CZ · Registration 3004784537

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
3004784537
FEI Number
3004784537
Entity Name
STERIS AST CZ s.r.o.
City/State/Country
VELKA BITES Vysocina, CZ
Establishment Address
PRUMYSLOVA ZONA KOSIKOV, VELKA BITES Vysocina 595 01, CZ
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
STERIS Corporation (Owner Number: 10042227)
Owner / Operator Contact Address
5960 Heisley Road, Mentor, OH 44060, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Arrow1600 (VB) - Arrow Vessel Catheter Kit ContractMed (VB) - Vaginal CT / MR Multi Channel Applicator Set Lisi34951 (ED) - MULTIPLE ORTHOPED. MANUAL INSTRUMEN Noraker11562 (MS) - ARTHREX QUICKSET DELIVERING GUN; GRAFTYS QUICKSET DELIVERING GUN Newclip11561 (MS) - Activ pins; ACTIVE Ankle pins; ACTIVE Ankle rescue kit; ACTIVE Ankle template; Alians Fragment Spec Newclip11561 (MS) - Foot & Hand Motion screw spatula; Footmotion pin; HTO pin; Large screw pins Shoulder pins Newclip11561 (MS) - Clavicle Plate pins; Clavicle Template for KIT; Distal Radius fast drilling handle; Distal Radius pi Newclip11561 (MS) - Distal Radius Plate template; Distal Radius rescue kit; Elbow pin; Foot & Hand Motion Pins; Intuitive5779 (VB) - TUBE SET WITH SMOKE EVACUATION Arrow1600 (VB) - FlexTip Plus Epidural Catheterization Set Arrow1600 (VB) - FlexTip Plus Epidural Catheter Arrow1600 (VB) - Arrowg+ard Blue Central Venous Catheter with PSI Arrow1600 (VB) - Arrow Central Venous Catheter Arrow1600 (VB) - Arrowg+ard Blue Central Venous Catheter GoldenSeason (KK) - NAR Wound packing gauze ContractMed (VB) - Compass Guiding Introducer Sheath; DuraSheath Introducer Sheath System ContractMed (VB) - Comfort Catheter System; CT/MR OncoSmart Catheter System Arrow1600 (VB) - Arrow Percutaneous Sheath Introducer Kit Novanta11862 (VB) - ENDOFLATOR + Arrow1600 (VB) - ArrowFlexBlock Continuous Peripheral Nerve Block Set Arrow1600 (VB) - FlexBlock Arrow1600 (VB) - Arrow Two-Lumen Hemodialysis Catheter ContractMed (VB) - Interstitial Ring CT/MR Applicator Set & Utrecht Interstitial Fletcher CT/MR Applicator Set Arrow1600 (VB) - Arrow MAC Two-Lumen Central Venous Access Kit CHMuller (RB) - Loop-X Disposable Sterile Drape Set Arrow1600 (VB) - Arrow Two-Lumen Hemodialysis Catheter ContractMed (VB) - Advanced Gynecological Applicator Arrow1600 (VB) - Arrow Central Venous Catheter Arrow1600 (VB) - Arrow Two-Lumen Hemodialysis Catheter Arrow1600 (VB) - Arrowg+ard Blue Central Venous Catheter Arrow1600 (VB) - Arrow Two-Lumen Hemodialysis Catheter Arrow1600 (VB) - Arrow Central Venous Catheter ContractMed (VB) - Fortress Introducer Sheath System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-11-18
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2016-11-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2026-04-30
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2026-04-30
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2019-03-01
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2019-03-01
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2019-03-01
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-08-22
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2017-04-24
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2014-11-13
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2013-04-08
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-01-15
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2021-02-22
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2014-11-13
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2024-10-30
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2024-10-30
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2014-11-14
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2014-11-14
EZO Urethrotome Gastroenterology, Urology Class 2 876.4770 2014-11-14
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2025-08-22
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2014-11-14
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-09-09
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2025-09-09
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2015-10-28
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2020-06-11
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2023-02-20
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2023-02-20
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2023-02-20
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2014-11-14
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2023-01-11
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-01-11
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2016-11-18
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2016-11-18
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2013-04-08
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2014-11-13
OSV Insufflator, Endoscopic Vessel Harvesting Obstetrics/Gynecology Class 2 884.1730 2025-11-19
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2025-11-19
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2014-11-14
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2014-11-13
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2014-11-13
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2019-03-01
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2019-03-01
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2019-03-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-11-18
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2016-11-18
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2014-11-14
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2013-04-08
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2025-08-22
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-08-22
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2014-11-14
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2022-11-30
JOS Electrode, Electrosurgical General, Plastic Surgery Class 2 878.4400 2019-03-01
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2019-03-01
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2020-05-26
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2014-11-13
LFJ Catheter, Subclavian Gastroenterology, Urology Class 2 876.5540 2014-11-13
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2017-02-16
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2014-11-14
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2014-11-13
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2014-11-14
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2022-11-30
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2014-11-14
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2022-11-30
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2014-11-13
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-01-11
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2023-01-11
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2014-11-14
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2014-11-14

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: Synergy Health 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 510(k) Records

510(k) Number Applicant Device Name Decision Date
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0001-2010 Penumbra Inc. 2
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04 Bard Peripheral Vascular 2
Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124

Similar Registrations

Registration Number Establishment Name Location
3007353760 ENERGIST LIMITED Swansea, GB
3005064998 RDI INC. Mount Kisco, NY, US
3020623326 TRIWORKS GROUP S.R.L. Palata Campobasso, IT
3012616488 BRERA MEDICAL INCORPORATED Northborough, MA, US
3012940012 Sutter Medical Technologies USA Inc. Alpharetta, GA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004784537. Last updated year: 2026. Please use registration number 3004784537 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.