FDA Registration
Active
🇮🇹 Italy
7001-3926 - INJECTION SITE
Reg #: 3004960482
·
FEI: 3004960482
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ELCAM MEDICAL ITALY SPA
- Registration Number
- 3004960482
- FEI Number
- 3004960482
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15, VIA EMILIA-ROMAGNA
- City
- CARPI Modena
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K855039
Owner / Operator
- Firm Name
- ELCAM MEDICAL ITALY SPA
- Operator Number
- 9094403
- Address
- 15, VIA EMILIA-ROMAGNA, --
- City
- CARPI
- State
- Modena
- Postal Code
- 41012
- Country
- IT
- Correspondent
- Chiara - Candini
US Agent
- Business Name
- ELCAM MEDICAL INC.
- Contact Name
- Tomer Gil
- Address
- 1 University Plz, SUITE 511
- City
- Hackensack
- State
- NJ
- ZIP
- 07601
- Country
- US
- [email protected]
- Phone
- 201 4571120 ext. 112
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Adaptor, Catheter | GCE | Class 1 | General, Plastic Surgery | No | 2006-11-08 |
Proprietary Names
7001-3926 - INJECTION SITE
175IBLSSC - CATHETHER INJECTION PORT
Establishment Types
Manufacture Medical Device