FDA Registration
Active
🇹🇷 Türkiye
Blade
Reg #: 3014479313
·
FEI: 3014479313
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI
- Registration Number
- 3014479313
- FEI Number
- 3014479313
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NO:4 MIMAR SINAN MAHALLESI NAMIK KEMAL CADDESI AYDIN SOKAK, ATASEHIR 34762, Istanbul (Anatolia) Turkey
- City
- Istanbul
- Country
- TR
Regulatory Submissions
- 510(k) Number
- K170312
Owner / Operator
- Firm Name
- SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI
- Operator Number
- 10089530
- Address
- NO:4 MIMAR SINAN MAHALLESI NAMIK KEMAL CADDESI AYDIN SOKAK, ATASEHIR 34762, Istanbul (Anatolia) Turkey
- City
- Istanbul
- State
- TR-34
- Postal Code
- 34758
- 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 |
|---|---|---|---|---|---|
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2024-11-18 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2024-11-18 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2024-11-18 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2024-11-18 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2024-11-18 |
| Saw, Pneumatically Powered | KFK | Class 1 | General, Plastic Surgery | No | 2024-11-18 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2024-11-18 |
Proprietary Names
Blade
Establishment Types
Export Device to the United States But Perform No Other Operation on Device