FDA Registration
Active
🇺🇸 United States
APEX MEDICAL TECHNOLOGIES, INC.
Reg #: 2025773
·
FEI: 2025773
·
Expires 2026
Products
6
Proprietary Names
3
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- APEX MEDICAL TECHNOLOGIES, INC.
- Registration Number
- 2025773
- FEI Number
- 2025773
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10064 Mesa Ridge Ct Ste 202
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K954791
Owner / Operator
- Firm Name
- APEX MEDICAL TECHNOLOGIES, INC.
- Operator Number
- 2025773
- Address
- 10064 MESA RIDGE CT., #202, --
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Loraine McNulty
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Condom | HIS | Class 2 | Obstetrics/Gynecology | No | 2011-11-25 |
| Endoscopic Ultrasound System, Gastroenterology-Urology | ODG | Class 2 | Gastroenterology, Urology | No | 2018-11-12 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2018-11-12 |
| Dilator, Vessel, Surgical | DWP | Class 2 | Cardiovascular | No | 2013-01-08 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 1992-10-05 |
| Device, Specimen Collection | LIO | Class 1 | Microbiology | No | 2013-01-01 |
Proprietary Names
Male-FactorPakTM
Hy-geneTM Seminal Fluid Collection Kit
EndosacTM Seamless Specimen Collection Pouch
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)