FDA Registration
Active
🇹🇷 Türkiye
CODE 865 REFLEX AFO
Reg #: 3009303371
·
FEI: 3009303371
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Variteks Ortopedi Sanayi A.S.
- Registration Number
- 3009303371
- FEI Number
- 3009303371
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Ferhatpasa Sb Mah. Menekse Sk., Variteks Blok No:3 Ic Kapi No:Z1
- City
- Catalca Istanbul
- Country
- TR
Owner / Operator
- Firm Name
- Variteks Ortopedi Sanayi A.S.
- Operator Number
- 10036107
- Address
- Ferhatpasa Sb Mah. Menekse Sk., Variteks Blok No:3 Ic Kapi No:Z1
- City
- ?stanbul
- State
- TR-NOTA
- Postal Code
- 34540
- Country
- TR
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2013-06-24 |
Proprietary Names
CODE 865 REFLEX AFO
CODE 864 AFO (Foot guard)
CODE 863 DROP FOOT SUPPORT
CODE 320 KNEE IMMOBILIZER
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device