FDA Registration
Active
🇹🇷 Türkiye
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Reg #: 3015453963
·
FEI: 3015453963
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI
- Registration Number
- 3015453963
- FEI Number
- 3015453963
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Cevizli Mah. Tansel Cad., No:12-18 Bulut Plaza D:32-33-34
- City
- Maltepe Istanbul
- Country
- TR
Regulatory Submissions
- 510(k) Number
- K170312
Owner / Operator
- Firm Name
- Cardimed Asia Medikal Sanayi ve Ticaret Ltd Sti
- Operator Number
- 10060492
- Address
- Cevizli Mah. Tansel Cad, No:12-18 Bulut Plaza D:32-33-34
- City
- Maltepe
- State
- Istanbul
- Postal Code
- 34846
- Country
- TR
US Agent
- Business Name
- ADVANCED INVENTORY INC
- Contact Name
- Jason Einhorn
- Address
- 9645 Willow Ln
- City
- Mokena
- State
- IL
- ZIP
- 60448
- Country
- US
- [email protected]
- Phone
- 888 4162409
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2024-02-12 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2024-02-12 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2024-02-12 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2024-02-12 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2024-02-12 |
| Saw, Pneumatically Powered | KFK | Class 1 | General, Plastic Surgery | No | 2024-02-12 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2024-02-12 |
Proprietary Names
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Establishment Types
Export Device to the United States But Perform No Other Operation on Device