FDA Registration
Active
🇰🇷 South Korea
HUVITZ CO., LTD.
Reg #: 9616199
·
FEI: 3003768492
·
Expires 2026
Products
15
Proprietary Names
51
Establishment Types
3
Classifications
15
Registration Details
- Registration Name
- HUVITZ CO., LTD.
- Registration Number
- 9616199
- FEI Number
- 3003768492
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 38, Burim-ro 170beon-gil, Dongan-gu
- City
- Anyang-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K093639
Owner / Operator
- Firm Name
- HUVITZ CO., LTD.
- Operator Number
- 9039310
- Address
- 38, Burim-ro 170beon-gil, Dongan-gu
- City
- Anyang-si
- State
- Gyeonggi
- Postal Code
- 14055
- Country
- KR
- Correspondent
- Hyung Min Heo
US Agent
- Business Name
- Mtech Group LLC
- Contact Name
- Dave Kim
- Address
- 7505 Fannin St Ste 610
- City
- Houston
- State
- TX
- ZIP
- 77054
- Country
- US
- [email protected]
- Phone
- 713 4672607
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | Class 1 | Ophthalmic | No | 1999-10-14 |
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2023-10-10 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2011-12-15 |
| Tomography, Optical Coherence | OBO | Class 2 | Ophthalmic | No | 2018-02-11 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2024-05-23 |
| System, Image Management, Ophthalmic | NFJ | Class 2 | Radiology | No | 2025-08-12 |
| Tonometer, Ac-Powered | HKX | Class 2 | Ophthalmic | No | 2016-08-10 |
| Projector, Ophthalmic | HOS | Class 1 | Ophthalmic | No | 2001-03-29 |
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2001-04-03 |
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2023-10-24 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2021-02-02 |
| Instrument, Measuring, Lens, Ac-Powered | HLM | Class 1 | Ophthalmic | No | 2001-03-29 |
| Perimeter, Automatic, Ac-Powered | HPT | Class 1 | Ophthalmic | No | 2022-06-10 |
| Topographer, Corneal, Ac-Powered | MMQ | Class 1 | Ophthalmic | No | 2021-02-02 |
| Table, Instrument, Powered, Ophthalmic | HRJ | Class 1 | Ophthalmic | No | 2013-03-22 |
Proprietary Names
Refractor, manual, non-powered, including phoropter
HDR-7000
HDR-9000
HDR-7000P
HDR-7100P
Optical Biometer, HBM-1
Chart, visual acuity
HDC-9100PF
HDC-9100N
HDC-7000
HDC-100
Tomography, optical coherence(HOCT-1, HOCT-1F)
Biomicroscope, slit-lamp, ac-powered
HS-7500
HS-5500
HS-7000
Lilivis CAD L-CAD
OCTiX IntraOral Scanner LSO-100
LS-100-TIP-3R
Lilivis Scan LS-100
K073190
Integrated image server;HIIS-1
Tonometer, ac-powered
HNT-1
HNT-1P
HTR-1A
Projector, ophthalmic
HCP-7000
ERK-9100
HRK-8000A
HRK-7000A
HRK-9000A
HRK-1
HRK-8100A
Vision Screener, HVS-1
Applanation Tonometer, HT-5000
System, image management, ophthalmic
Fundus Camera HFC-1
Instrument, measuring, lens, ac-powered
HLM-1
HLM-9000
HLM-7000P
HVF-100
HIS-5000U( (10M, 5M, 1.4M)
topographer, corneal
Corneal Topographer, HTG-1
Auto Ref-Topographer, HRKT-1
Table, instrument, powered, ophthalmic
CIT-4000
HRT-7000
VISUREF 600
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)