FDA Registration
Active
🇰🇷 South Korea
POTEC CO., LTD.
Reg #: 3003984265
·
FEI: 3003984265
·
Expires 2026
Products
4
Proprietary Names
36
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- POTEC CO., LTD.
- Registration Number
- 3003984265
- FEI Number
- 3003984265
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 40-4, Techno 2-ro, Yuseong-gu
- City
- DAEJEON
- Country
- KR
Owner / Operator
- Firm Name
- POTEC CO., LTD.
- Operator Number
- 9059372
- Address
- 40-4, Techno 2-ro, Yuseong-gu, --
- City
- DAEJEON
- State
- KR-30
- Postal Code
- 34015
- Country
- KR
- Correspondent
- Harry - Hazra
US Agent
- Business Name
- US Ophthalmic LLC
- Contact Name
- Gustavo Lancewicki
- Address
- 9990 Nw 14th St Ste 105
- City
- Doral
- State
- FL
- ZIP
- 33172
- Country
- US
- [email protected]
- Phone
- 305 5034091
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2003-10-28 |
| Instrument, Measuring, Lens, Ac-Powered | HLM | Class 1 | Ophthalmic | No | 2004-11-30 |
| Projector, Ophthalmic | HOS | Class 1 | Ophthalmic | No | 2004-11-30 |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | Class 1 | Ophthalmic | No | 2006-09-19 |
Proprietary Names
POTEC PRK 5000
POTEC PRK-5000L
POTEC PRK-7000
POTEC PRK-8000
EZER ERK-BH
EZER ERK-H
HRK-9900
HRK-9000
POTEC PRK-6000
POTEC PRK-9000
POTEC PLM-8000PD
POTEC PLM-8000
POTEC PLM-6100
POTEC PLM-6100 PD
EZER ELM-BH
EZER ELM-BH-PD
POTEC PLM-6000
POTEC PACP-6000
POTEC PACP-7000L
POTEC PLC-7100
POTEC PLC-7100pola
POTEC PLC-8000 Polar
POTEC PLC-8000
POTEC PLC-7000
POTEC PACP-7000
POTEC PLC-7000 Polar
PACP-8000
EZER EDC-BH
POTEC PLC-9000 Polar
POTEC PACP-6100
POTEC PLC-9000
POTEC PDR-7000
VISION TESTER
POTEC PAV-6100
Digital refractor
EZER EDR-H
Establishment Types
Manufacture Medical Device