FDA Registration
Active
🇮🇹 Italy
SAPI MED S.P.A
Reg #: 3004443374
·
FEI: 3004443374
·
Expires 2026
Products
7
Proprietary Names
26
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- SAPI MED S.P.A
- Registration Number
- 3004443374
- FEI Number
- 3004443374
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via della Chimica 6 - Z. I. D3
- City
- ALESSANDRIA
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K070881
Owner / Operator
- Firm Name
- SAPI MED S.P.A
- Operator Number
- 9060655
- Address
- Via della Chimica, 6, Z.I. D3
- City
- ALESSANDRIA
- State
- IT-AL
- Postal Code
- 15121
- Country
- IT
- Correspondent
- Paola - Oddenino
US Agent
- Business Name
- CEO Adler MicroMed
- Contact Name
- Brian Chandler
- Address
- 6842 Elaine Way
- City
- San Diego
- State
- CA
- ZIP
- 92120
- Country
- US
- [email protected]
- Phone
- 484 9957919
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | Class 1 | Gastroenterology, Urology | No | 2004-01-15 |
| Ligator, Hemorrhoidal | FHN | Class 2 | Gastroenterology, Urology | No | 2007-12-16 |
| Sigmoidoscope, Rigid, Non-Electrical | KDM | Class 2 | Gastroenterology, Urology | No | 2007-12-16 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2016-04-05 |
| Anoscope And Accessories | FER | Class 2 | Gastroenterology, Urology | No | 2007-12-16 |
| Dilator, Rectal | FFP | Class 1 | Gastroenterology, Urology | No | 2004-01-15 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 2016-03-30 |
Proprietary Names
GLF 100
LEM - Suction hemorrhoidal ligator
LEM - Traction banding ligator
LEM - Suction banding ligator
LEM Traction hemorrhoidal ligator
LEM - Disposable banding ligator
LEM - Self-Suction
LEM 4 Rings
Procto-sigmoidoscope Pediatric
Procto-sigmoidoscope with Grip
Proctoscope Short
Rigid Procto-sigmoidoscope Kit MRP
Ecolite
Pen LED Light
SELF-LIGHT - Adult Anoscope
THE BEAK LIGHTED RETRACTOR
BASILE'S CONE RETRACTOR
SELF-LIGHT - Pediatric Anoscope
SELF-LIGHT - Therapeutic Anoscope
Cylindrical operative anal retractr
L-Bet88
Dilastom
Dilatan
Dilatan Plus
Gull
ERODe
Establishment Types
Manufacture Medical Device