FDA Registration
Active
🇹🇷 Türkiye
536820 VACUSERA® 10 ml Urine Tube - Chlorhexidine
Reg #: 3005690789
·
FEI: 3005690789
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- DISERA TIBBI MALZEME LOJISTIK SANAYI TIC. A.S.
- Registration Number
- 3005690789
- FEI Number
- 3005690789
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Ibni Melek OSB, Mahallesi. Tosbi Yol 5 Sk. NO:46, 35900
- City
- Tire Izmir
- Country
- TR
Owner / Operator
- Firm Name
- Disera Tibbi Malzeme Lojistik Sanayi Tic. A.S.
- Operator Number
- 10090595
- Address
- Ibni Melek OSB, Mahallesi. Tosbi Yol 5 Sk. NO:46, 35900
- City
- Tire
- State
- Izmir
- Postal Code
- 35900
- Country
- TR
- Correspondent
- Kenan Deniz BUYUKAKMAN
US Agent
- Business Name
- CALBIOTECH, INC.
- Contact Name
- David Barka
- Address
- 1935 Cordell Court
- City
- El Cajon
- State
- CA
- ZIP
- 92020
- Country
- US
- [email protected]
- Phone
- 619 7083999
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2024-04-17 |
Proprietary Names
536820 VACUSERA® 10 ml Urine Tube - Chlorhexidine
535806 VACUSERA® 6 ml Urine Tube
503026 VACUSERA® Urine Beaker with Integrated Holder
536800 VACUSERA® 10 ml Urine Tube
535816 VACUSERA® 6 ml Urine Tube - Boric Acid
536828 VACUSERA® 8 ml Urine Tube - Chlorhexidine
536810 VACUSERA® 10 ml Urine Tube - Boric Acid
503001 VACUSERA® Urine Beaker Red Cap
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