FDA Registration
Active
🇹🇷 Türkiye
Geotek Disposable Core Biopsy Needles (Estacore-Pro Automatic Biopsy Needle, Semiautomatic Biopsy Needle, Maxicore-M Biopsy Needle and Instrument)
Reg #: 3013727803
·
FEI: 3013727803
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GEOTEK MEDIKAL VE SAGLIK HIZ. LTD. STI
- Registration Number
- 3013727803
- FEI Number
- 3013727803
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Eskisehir Yolu 42. Km ASO 2 Alci OSB 2014 Cad No:11 Sincan
- City
- Ankara
- Country
- TR
Regulatory Submissions
- 510(k) Number
- K223300
Owner / Operator
- Firm Name
- Geotek Medikal ve Saglik HIz. Ltd. Sti
- Operator Number
- 10056293
- Address
- Eskisehir Yolu 42. Km ASO 2 Alci OSB 2014 Cad No:11 Sincan
- City
- Ankara
- State
- TR-NOTA
- Postal Code
- 06909
- Country
- TR
- Correspondent
- Latif Iba
US Agent
- Business Name
- Medes USA C/O Matan Arazy
- Contact Name
- Benny Arazy
- Address
- 15201 6th Ave NE, ,
- City
- Shoreline
- State
- WA
- ZIP
- 98155
- Country
- US
- [email protected]
- Phone
- 415 9921126
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2023-09-07 |
Proprietary Names
Geotek Disposable Core Biopsy Needles (Estacore-Pro Automatic Biopsy Needle, Semiautomatic Biopsy Needle, Maxicore-M Biopsy Needle and Instrument)
Establishment Types
Manufacture Medical Device