FDA Registration
Active
🇨🇭 Switzerland
COMEPSA LTD
Reg #: 3009328501
·
FEI: 3009328501
·
Expires 2026
Products
12
Proprietary Names
2
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- COMEPSA LTD
- Registration Number
- 3009328501
- FEI Number
- 3009328501
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Livio 24
- City
- Chiasso Ticino
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K080235
Owner / Operator
- Firm Name
- COMEPSA LTD
- Operator Number
- 10080291
- Address
- Via Livio 24
- City
- Chiasso
- State
- CH-NOTA
- Postal Code
- 6830
- Country
- CH
- Correspondent
- Marco Maghetti
US Agent
- Business Name
- Jet Air Service
- Contact Name
- Joe Pobdela
- Address
- 1319 N Broad St
- City
- Hillside
- State
- NJ
- ZIP
- 07205
- Country
- US
- [email protected]
- Phone
- 718 6567430
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2026-05-06 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2026-04-09 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2024-09-27 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2024-03-28 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2021-03-04 |
| Lung Sound Monitor | OCR | Class 2 | Cardiovascular | No | 2026-01-22 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2023-09-13 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2023-09-13 |
| Filter, Infusion Line | FPB | Class 2 | General Hospital | No | 2026-04-09 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2024-09-27 |
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2024-09-27 |
| Anoscope And Accessories | FER | Class 2 | Gastroenterology, Urology | No | 2024-09-27 |
Proprietary Names
GREINER-NEEDLE,HYPODERMIC, SAFETY INFUSION SET
SET, ADMINISTRATION, INTRAVASCULAR
Establishment Types
Export Device to the United States But Perform No Other Operation on Device