FDA Registration
Active
🇫🇷 France
Vial Adapter o13mm Without Filter
Reg #: 3010329663
·
FEI: 3010329663
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IONISOS Pouzauges
- Registration Number
- 3010329663
- FEI Number
- 3010329663
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ZI de Montifaut
- City
- Pouzauges Vendee
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K220856
Owner / Operator
- Firm Name
- EPIONE BIDCO
- Operator Number
- 10042490
- Address
- 415 allee de Frenes, bat Squale
- City
- LIMONEST
- State
- Rhone
- Postal Code
- 69760
- Country
- FR
- Correspondent
- Alexandra Basset
US Agent
- Business Name
- Dawa Medical LLC
- Contact Name
- Stephan Toupin
- Address
- 7320 Nw 12th St Ste 103
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 786 7131159
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2023-01-03 |
Proprietary Names
Vial Adapter o13mm Without Filter
Vial Adapter o13mm Filter 5um
Vial Adapter O13mm Filter 15um Set, i.v. fluid transfer
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)