FDA Registration
Active
🇺🇸 United States
BIOMERICS
Reg #: 3008998256
·
FEI: 3008998256
·
Expires 2026
Products
17
Proprietary Names
20
Establishment Types
1
Classifications
17
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Registration Details
- Registration Name
- BIOMERICS
- Registration Number
- 3008998256
- FEI Number
- 3008998256
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6030 W Harold Gatty Drive
- City
- Salt Lake City
- State
- UT
- ZIP
- 84116
- Country
- US
Owner / Operator
- Firm Name
- Biomerics
- Operator Number
- 10042380
- Address
- 6030 W Harold Gatty Drive
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84116
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2025-09-18 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2012-11-21 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2020-11-20 |
| Catheter For Crossing Total Occlusions | PDU | Class 2 | Cardiovascular | No | 2023-12-27 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2020-11-20 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2020-11-20 |
| Catheter, Hemodialysis, Implanted | MSD | Class 2 | Gastroenterology, Urology | No | 2021-04-06 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2020-12-15 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2020-11-20 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2024-04-29 |
| Cannula, Catheter | DQR | Class 2 | Cardiovascular | No | 2020-11-20 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2019-11-26 |
| System, Perfusion, Kidney | KDN | Class 2 | Gastroenterology, Urology | No | 2016-02-09 |
| Needle, Interosseous | MHC | Class 2 | General Hospital | No | 2021-03-09 |
| Apparatus, Cautery, Radiofrequency, Ac-Powered | HQR | Class 2 | Ophthalmic | No | 2020-08-27 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2020-08-27 |
| Catheter Introducer Kit | OFD | Class 2 | Cardiovascular | No | 2022-12-19 |
Proprietary Names
PeriCross Epicardial Access Kit
Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode
Peripheral Cannulae
Crosser iQ CTO Recanalization System
Arterial Cannulae
Intra-Aortic Occlusion Catheter (IntraClude)
Arterial Cannulae (EndoReturn)
Disposable-Tissue Retractor
Pristine Long-Term Hemodialysis Catheter
Trabex+
Trabex
Disposable-Knot Pusher
Vesta
Uretero 1 Video Ureteroscope System
BD Intraosseous Vascular Access System
LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)
BD Intraosseous Infusion System
Trabectome
Insertion Accessories
PIKA Convenience Kit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)