FDA Registration
Active
🇹🇷 Türkiye
Administration (IV) Set
Reg #: 3006534321
·
FEI: 3006534321
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.
- Registration Number
- 3006534321
- FEI Number
- 3006534321
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Ibni Melek Mah., Organize Sanayi Bolgesi
- City
- Tire Izmir
- Country
- TR
Regulatory Submissions
- 510(k) Number
- K123049
Owner / Operator
- Firm Name
- Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.
- Operator Number
- 9099982
- Address
- Ibni Melek Mah., Organize Sanayi Bolgesi
- City
- Tire
- State
- Izmir
- Postal Code
- 35900
- Country
- TR
US Agent
- Business Name
- Regulatory Insight, Inc.
- Contact Name
- KEVIN WALLS
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2013-11-25 |
Proprietary Names
Administration (IV) Set
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)