FDA Registration
Active
🇹🇷 Türkiye
MD
Reg #: 3021632375
·
FEI: 3021632375
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IVUS ILAC SANAYI VE TICARET AS
- Registration Number
- 3021632375
- FEI Number
- 3021632375
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Yesilkoy cad. No 25 Florya Bakirkoy
- City
- Istanbul
- Country
- TR
Regulatory Submissions
- 510(k) Number
- K130435
Owner / Operator
- Firm Name
- IVUS ILAC SANAYI VE TICARET AS
- Operator Number
- 10084070
- Address
- Yesilkoy cad. No 25 Florya Bakirkoy
- City
- Istanbul
- State
- TR-34
- Postal Code
- 34153
- Country
- TR
- Correspondent
- Abuzer A Tandogan
US Agent
- Business Name
- IVUS MEDICAL SUPPLY
- Contact Name
- Abuzer Tandogan
- Address
- 6805 Rathbone PI
- City
- Gainesville
- State
- VA
- ZIP
- 20155
- Country
- US
- [email protected]
- Phone
- 202 9938601
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2022-02-15 |
Proprietary Names
MD
Establishment Types
Export Device to the United States But Perform No Other Operation on Device