FDA Registration
Active
🇺🇸 United States
SEISA MEDICAL INC
Reg #: 3006131984
·
FEI: 3006131984
·
Expires 2026
Products
17
Proprietary Names
9
Establishment Types
1
Classifications
17
Research this establishment in seconds
The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.
Free to try · every answer cites its records
Registration Details
- Registration Name
- SEISA MEDICAL INC
- Registration Number
- 3006131984
- FEI Number
- 3006131984
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 9005 Montana Ave
- City
- El Paso
- State
- TX
- ZIP
- 79925
- Country
- US
Regulatory Submissions
- 510(k) Number
- K893888
- PMA Number
- P020018
Owner / Operator
- Firm Name
- SEISA MEDICAL -TEKNI PLEX
- Operator Number
- 10023408
- Address
- 9005 Montana Ave
- City
- El Paso
- State
- TX
- Postal Code
- 79925
- Country
- US
- Correspondent
- Jason Skramsted
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2022-11-17 |
| Collector, Ostomy | EXB | Class 1 | Gastroenterology, Urology | No | 2022-11-17 |
| Pump, Breast, Non-Powered | HGY | Class 1 | Obstetrics/Gynecology | No | 2014-12-19 |
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2014-12-19 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2022-11-17 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2022-11-17 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2022-11-17 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2022-11-17 |
| Enema Kit | FCE | Class 1 | Gastroenterology, Urology | No | 2022-11-17 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2022-11-17 |
| System, Abortion, Vacuum | HHI | Class 2 | Obstetrics/Gynecology | No | 2022-11-17 |
| Curette, Suction, Endometrial (And Accessories) | HHK | Class 2 | Obstetrics/Gynecology | No | 2022-11-17 |
| System, Endovascular Graft, Aortic Aneurysm Treatment | MIH | Class 3 | Unknown | No | 2022-11-17 |
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | Class 1 | General, Plastic Surgery | No | 2022-11-17 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2022-11-17 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2022-11-17 |
| Protector, Ostomy | EXE | Class 1 | Gastroenterology, Urology | No | 2022-11-17 |
Proprietary Names
HOLLISTER INC
AMEDA INC
OLYMPUS GYRUS
DermaClip® US, LLC
COOK MEDICAL INC
COOK INC.
cook inc
Burpee Medsystems, LLC
Bard Peripheral Vascular, Inc.
Establishment Types
Complaint File Establishment per 21 CFR 820.198