FDA Registration
Active
🇨🇿 Czechia
STERIS AST CZ s.r.o.
Reg #: 3004784537
·
FEI: 3004784537
·
Expires 2026
Products
34
Proprietary Names
36
Establishment Types
1
Classifications
34
Registration Details
- Registration Name
- STERIS AST CZ s.r.o.
- Registration Number
- 3004784537
- FEI Number
- 3004784537
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PRUMYSLOVA ZONA KOSIKOV
- City
- VELKA BITES Vysocina
- Country
- CZ
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10042227
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- Synergy Health
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 4687462
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2016-11-18 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2016-11-18 |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2026-04-30 |
| Resectoscope | FJL | Class 2 | Gastroenterology, Urology | No | 2019-03-01 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2019-03-01 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2025-08-22 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2017-04-24 |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | Class 2 | Radiology | No | 2013-04-08 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-15 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2021-02-22 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2024-10-30 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2024-10-30 |
| Urethrotome | EZO | Class 2 | Gastroenterology, Urology | No | 2014-11-14 |
| Catheter, Conduction, Anesthetic | BSO | Class 2 | Anesthesiology | No | 2025-08-22 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2025-09-09 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2025-09-09 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2020-06-11 |
| Catheter, Hemodialysis, Non-Implanted | MPB | Class 2 | Gastroenterology, Urology | No | 2014-11-14 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2023-01-11 |
| Insufflator, Endoscopic Vessel Harvesting | OSV | Class 2 | Obstetrics/Gynecology | No | 2025-11-19 |
| Snare, Flexible | FDI | Class 2 | Gastroenterology, Urology | No | 2022-11-30 |
| Electrode, Electrosurgical | JOS | Class 2 | General, Plastic Surgery | No | 2019-03-01 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2020-05-26 |
| Catheter, Subclavian | LFJ | Class 2 | Gastroenterology, Urology | No | 2014-11-13 |
| Catheter, Flow Directed | DYG | Class 2 | Cardiovascular | No | 2014-11-13 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2022-11-30 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2022-11-30 |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | Class 2 | Gastroenterology, Urology | No | 2026-03-19 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2014-01-10 |
| Endoscope, Ac-Powered And Accessories | GCP | Class 2 | Gastroenterology, Urology | No | 2014-11-14 |
| Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | CBI | Class 2 | Anesthesiology | No | 2015-11-03 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2013-07-09 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2014-11-13 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2014-11-14 |
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
ContractMed (VB) - Advanced Gynecological Applicator
ContractMed (VB) - Fortress Introducer Sheath System
Skymed16209 (VB) - Extension Feeding Set with ENFit Connectors; Medicina Extension Feeding Set with ENFit Connectors
GoldenSeason (KK) - NAR COMPRESSED GAUZE; NAR S-ROLLED GAUZE; NAR Z-FOLD GAUZE
Arrow1600 (VB) - EZ Blocker
ContractMed (VB) - Guide Sheath
Stirilab11801 (VB) - EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE
Arrow1600 (VB) - Arrow Seldinger Arterial Catheterization Devices
ContractMed (VB) - Proguide Needle Set; ProGuide Obturator
Arrow1600 (VB) - Arrow Arterial Catheter
ContractMed (VB) - FORTRESS Introducer Sheath System
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)