FDA Registration
Active
🇹🇷 Türkiye
DISERA TIBBI MALZEME LOJISTIK SANAYI TIC. A.S.
Reg #: 3005690789
·
FEI: 3005690789
·
Expires 2026
Products
4
Proprietary Names
22
Establishment Types
3
Classifications
4
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Registration Details
- Registration Name
- DISERA TIBBI MALZEME LOJISTIK SANAYI TIC. A.S.
- Registration Number
- 3005690789
- FEI Number
- 3005690789
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Ibni Melek OSB, Mahallesi. Tosbi , 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 |
|---|---|---|---|---|---|
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2025-01-16 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2024-04-17 |
| Catheter, Coude | EZC | Class 2 | Gastroenterology, Urology | No | 2026-02-09 |
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2026-02-09 |
Proprietary Names
VACUSERA® AUTOMATIC PINKTOURNIQUET FOR CHILDREN
VACUSERA® AUTOMATIC GREEN TOURNIQUET FOR CHILDREN
VACUSERA® PRF TUBES
VACUSERA® SAFETY HOLDER
VACUSERA® DISPOSABLE TOURNIQUET
VACUSERA® LUER LOCK BLOOD COLLECTION HOLDER-MALE
VACUSERA® PRF TUBE
VACUSERA® LUER LOCK BLOOD COLLECTION HOLDER-FEMALE
VACUSERA® LUER ADAPTER 20 G + STANDARD HOLDER
VACUSERA® LUER ADAPTER 20G
VACUSERA® BLOOD COLLECTION NEEDLE HOLDER
VACUSERA® AUTOMATIC TOURNIQUET
536820 VACUSERA® 10 ml Urine Tube - Chlorhexidine
536810 VACUSERA® 10 ml Urine Tube - Boric Acid
503001 VACUSERA® Urine Beaker Red Cap
535816 VACUSERA® 6 ml Urine Tube - Boric Acid
536828 VACUSERA® 8 ml Urine Tube - Chlorhexidine
503026 VACUSERA® Urine Beaker with Integrated Holder
536800 VACUSERA® 10 ml Urine Tube
535806 VACUSERA® 6 ml Urine Tube
SimPro Now
GentleCath Hydrophilic
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Sterilize Medical Device for Another Party (Contract Sterilizer)