FDA Registration
Active
🇺🇸 United States
CATHTEK LLC
Reg #: 3027553380
·
FEI: 3027553380
·
Expires 2026
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- CATHTEK LLC
- Registration Number
- 3027553380
- FEI Number
- 3027553380
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4790 Walkertown Plaza Blvd
- City
- Walkertown
- State
- NC
- ZIP
- 27051
- Country
- US
Owner / Operator
- Firm Name
- Cathtek LLC
- Operator Number
- 10042470
- Address
- 3825 Reidsville Road
- City
- Winston Salem
- State
- NC
- Postal Code
- 27101
- Country
- US
- Correspondent
- Jessica Hughes
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2026-06-12 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2025-11-26 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2024-07-19 |
| Intra-Abdominal Pressure Monitoring Device | PHU | Class U | Unknown | No | 2024-07-19 |
| Graft Insertion Instrument For Endothelial Keratoplasty | OTZ | Class 1 | Ophthalmic | No | 2022-12-05 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-11-26 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)