FDA Registration
Active
🇫🇷 France
FILTRAY 2G Disposable Water Filters
Reg #: 3019907057
·
FEI: 3019907057
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INFIPLAST
- Registration Number
- 3019907057
- FEI Number
- 3019907057
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ZI OUEST II - BP14, 225 RUE DES COMBALETTES
- City
- OYONNAX Ain
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K191563
Owner / Operator
- Firm Name
- INFIPLAST
- Operator Number
- 10082105
- Address
- ZI OUEST II - BP14, 225 RUE DES COMBALETTES
- City
- OYONNAX
- State
- Ain
- Postal Code
- 01100
- Country
- FR
- Correspondent
- CATHERINE SANDOZ
US Agent
- Business Name
- MMA USA Inc.
- Contact Name
- Charles Sevigny
- Address
- 2915 Ogletown Road, Suite 2012
- City
- Newark
- State
- DE
- ZIP
- 19713
- Country
- US
- [email protected]
- Phone
- 412 9836511
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Water Purification, General Medical Use | NHV | Class 2 | Gastroenterology, Urology | No | 2021-07-08 |
Proprietary Names
FILTRAY 2G Disposable Water Filters
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)