FDA Registration
Active
🇹🇷 Türkiye
YENI BIYOTEKNOLOJI ANONIM SIRKETI
Reg #: 3035387168
·
FEI: 3035387168
·
Expires 2026
Products
5
Proprietary Names
9
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- YENI BIYOTEKNOLOJI ANONIM SIRKETI
- Registration Number
- 3035387168
- FEI Number
- 3035387168
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- MORFOLOJI D:Z, NO:56-20 INCIRALTI MAHALLESI MITHATPASA CADDESI
- City
- BALCOVA Izmir
- Country
- TR
Owner / Operator
- Firm Name
- YENI BIYOTEKNOLOJI ANONIM SIRKETI
- Operator Number
- 10092522
- Address
- MORFOLOJI D:Z, NO:56-20 INCIRALTI MAHALLESI MITHATPASA CADDESI
- City
- BALCOVA
- State
- Izmir
- Postal Code
- 35330
- Country
- TR
US Agent
- Business Name
- Liberty Management Group Ltd.
- Contact Name
- Manoj Zacharias
- Address
- 75 Executive Drive,, Suite 114,
- City
- Aurora
- State
- IL
- ZIP
- 60504
- Country
- US
- [email protected]
- Phone
- 630 2702921
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Media And Components, Synthetic Cell And Tissue Culture | KIT | Class 1 | Hematology | No | 2025-01-16 |
| Gram Negative Identification Panel | LQM | Class 1 | Microbiology | No | 2025-01-16 |
| Seminal Fluid, Antigen, Antiserum, Control | DGB | Class 1 | Immunology | No | 2025-01-16 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2025-01-16 |
| Material, Quality Control, Semen Analysis | NRF | Class 2 | Hematology | No | 2025-01-16 |
Proprietary Names
FLUSHMAX HEPES buffered cell culture Medium for use in ART KIT 1
IVFMAX Bicarbonate buffered cell culture medium for fertilization by IVF or ICSI
mHTFMAX HEPES buffered cell culture Medium for use in ART KIT 1
OILMAX High purity mineral oil
SpermCell Smartphone Applied Sperm Analyzer
EXOSID Exosome Isolation Device
TOROMAN Smart Handling Devices NRF 2
ROMAN & TOROMAN Smart Handling Devices
ROMAN Smart Handling Devices NRF 2
Establishment Types
Manufacture Medical Device