FDA Registration
Active
🇹🇷 Türkiye
VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S.
Reg #: 3017210488
·
FEI: 3017210488
·
Expires 2025
Products
7
Proprietary Names
0
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S.
- Registration Number
- 3017210488
- FEI Number
- 3017210488
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- FATIH MAH. 1191 SK. 26/2 A BLOK, GAZIEMIR
- City
- IZMIR
- Country
- TR
Regulatory Submissions
- 510(k) Number
- K170312
Owner / Operator
- Firm Name
- VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S.
- Operator Number
- 10076888
- Address
- FATIH MAH. 1191 SK. 26/2 A BLOK, GAZIEMIR
- City
- IZMIR
- State
- TR-35
- Postal Code
- 35410
- Country
- TR
- Correspondent
- ANIL ERTEKIN
US Agent
- Business Name
- Pragmatic Compliance dba FDAbasics
- Contact Name
- Jerry Doane
- Address
- 15815 SW 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2021-09-15 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2021-09-15 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2021-09-15 |
| Saw, Pneumatically Powered | KFK | Class 1 | General, Plastic Surgery | No | 2021-09-15 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2021-09-15 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2021-09-15 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2021-09-15 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device