FDA Registration
Active
🇲🇽 Mexico
SEI Medical S.A. de C.V.
Reg #: 9710641
·
FEI: 3003565456
·
Expires 2026
Products
66
Proprietary Names
26
Establishment Types
1
Classifications
66
Registration Details
- Registration Name
- SEI Medical S.A. de C.V.
- Registration Number
- 9710641
- FEI Number
- 3003565456
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ROBERTO FIERRO #6420 & FRANCISCO SARABIA, PARQUE INDUSTRIAL AEROPUERTO
- City
- Juarez Chihuahua
- Country
- MX
Owner / Operator
- Firm Name
- SEISA MEDICAL INC. d.b.a Tekni-Plex Healthcare
- Operator Number
- 9047964
- Address
- 615 S. DUPONT HIGHWAY
- City
- Dover
- State
- DE
- Postal Code
- 19901
- Country
- US
- Correspondent
- Cesar - Rios
US Agent
- Business Name
- SEI Medical - TekniPlex Healthcare
- Contact Name
- Cesar Coughanour
- Address
- 9005 Montana Ave
- City
- El Paso
- State
- TX
- ZIP
- 79925
- Country
- US
- [email protected]
- Phone
- 915 7744321 ext. 1612
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Case, Contact Lens | LRX | Class 2 | Ophthalmic | No | 2020-02-11 |
| Nursing Pad, Hydrogel | NTC | Class 1 | General Hospital | No | 2010-11-22 |
| Support, Scrotal, Therapeutic | FQJ | Class 1 | General Hospital | No | 2020-01-06 |
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | Class 1 | General, Plastic Surgery | No | 2022-11-03 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2014-01-02 |
| Orthosis, Moldable, Supportive, Skin Protective | MNE | Class 1 | Physical Medicine | No | 2026-04-21 |
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2010-11-22 |
| Pump, Breast, Non-Powered | HGY | Class 1 | Obstetrics/Gynecology | No | 2010-11-22 |
| Joint, Elbow, External Limb Component, Mechanical | IRD | Class 1 | Physical Medicine | No | 2018-05-08 |
| Belt, Pelvic, Traction | HSQ | Class 1 | Orthopedic | No | 2016-09-01 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2020-07-06 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2013-10-21 |
| Binder, Elastic | KMO | Class 1 | General Hospital | No | 2018-03-22 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2019-11-07 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2024-12-12 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2020-11-20 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2020-06-29 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 2018-03-22 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2010-11-19 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2025-12-11 |
| Pill Crusher/Cutter | OHY | Class 1 | General Hospital | No | 2019-10-09 |
| Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | GCA | Class 2 | Gastroenterology, Urology | No | 2011-02-25 |
| System, Endovascular Graft, Aortic Aneurysm Treatment | MIH | Class 3 | Unknown | No | 2011-04-25 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2011-04-25 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2016-08-31 |
| Scaffold, Dissection Repair | QCT | Class 3 | Unknown | No | 2021-05-21 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2020-06-29 |
| Shield, Nipple | HFS | Class 1 | General Hospital | No | 2010-11-19 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-01-28 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2025-09-26 |
| Collector, Ostomy | EXB | Class 1 | Gastroenterology, Urology | No | 2010-12-10 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2010-11-22 |
| Yoke Assembly, Medical Gas | CAM | Class 1 | Anesthesiology | No | 2020-06-29 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2016-08-31 |
| Dispenser, Solid Medication | NXB | Class 1 | Physical Medicine | No | 2019-10-03 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2020-05-05 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2014-10-09 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2014-10-09 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2018-06-28 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2010-11-22 |
| Joint, Shoulder, External Limb Component | IQQ | Class 1 | Physical Medicine | No | 2019-08-14 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2010-11-22 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2025-08-18 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2018-11-20 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2013-10-21 |
| Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | PYO | Class 1 | General Hospital | No | 2024-12-16 |
| Enema Kit | FCE | Class 1 | Gastroenterology, Urology | No | 2010-12-22 |
| Protector, Ostomy | EXE | Class 1 | Gastroenterology, Urology | No | 2010-11-19 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2020-01-23 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-02-13 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2020-06-29 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2020-06-29 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2011-05-16 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2020-06-29 |
| Dilator, Urethral | KOE | Class 2 | Gastroenterology, Urology | No | 2014-10-09 |
| Dilator, Catheter, Ureteral | EZN | Class 2 | Gastroenterology, Urology | No | 2014-10-09 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2018-10-08 |
| Orthosis, Sacroiliac, Soft | IPW | Class 1 | Physical Medicine | No | 2016-08-30 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2019-04-22 |
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2025-12-04 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2021-11-12 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2014-10-30 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2016-08-30 |
| Endoscopic Cytology Brush | FDX | Class 2 | Gastroenterology, Urology | No | 2010-11-22 |
| Curette, Suction, Endometrial (And Accessories) | HHK | Class 2 | Obstetrics/Gynecology | No | 2013-10-21 |
| System, Abortion, Vacuum | HHI | Class 2 | Obstetrics/Gynecology | No | 2013-10-21 |
Proprietary Names
Compass Health Brand Corporation
AMEDA INC.
Scott Specialties, Inc.
COOK INC.
Bard Peripheral Vascular, Inc.
ELASTIC THERAPY INC
SCOTT SPECIALTIES, INC.
Burpee Medsystems, LLC
OLYMPUS GYRUS
COMPASS HEALTH
International Biomedical LTD
HOLLISTER INC
ELASTIC THERAPY LLC
WILSON-COOK MEDICAL, INC
COOK MEDICAL INC
Philips Medical Systems International BV (Burpee Medsystems, LLC)
Cook Incorporated
COOK VASCULAR, INC
WILSON COOK
COMPASS HEALTH BRANDS
COOK UROLOGICAL, INC.
MEDI-DYNE
DermaClip® US, LLC
COOK UROLOGY INC
MEDI DYNE HEALTHCARE PRODUCTS
DERMACLIP US, LLC
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)