FDA Registration
Active
🇰🇷 South Korea
BIO PROTECH, INC.
Reg #: 9710582
·
FEI: 3003514332
·
Expires 2026
Products
12
Proprietary Names
17
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- BIO PROTECH, INC.
- Registration Number
- 9710582
- FEI Number
- 3003514332
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 151-3, Donghwagongdan-ro, Munmak-eup
- City
- Wonju-si Gangwon
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K020003
Owner / Operator
- Firm Name
- BIO PROTECH, INC.
- Operator Number
- 9048345
- Address
- 151-3, Donghwagongdan-ro, Munmak-eup
- City
- Wonju-si
- State
- Gangwon
- Postal Code
- 26365
- Country
- KR
- Correspondent
- Namhyun Cho
US Agent
- Business Name
- BIO PROTECH USA INC.
- Contact Name
- Ikro Park
- Address
- 13311 166th St Ste A
- City
- Cerritos
- State
- CA
- ZIP
- 90703
- Country
- US
- [email protected]
- Phone
- 909 4641464
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2024-03-21 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2007-12-04 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2012-07-25 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2009-12-18 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2008-02-11 |
| Apparatus, Exhaust, Surgical | FYD | Class 2 | General, Plastic Surgery | No | 2019-08-30 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2020-01-27 |
| Interferential Current Therapy | LIH | Class 2 | Neurology | No | 2010-12-27 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2011-06-23 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2007-12-22 |
| Electrode, Needle, Diagnostic Electromyograph | IKT | Class 2 | Physical Medicine | No | 2016-06-07 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2016-06-07 |
Proprietary Names
Smoke Evacuation Tubing
EvaQMax Laparo
TELECTRODE
PROTENS
Soft-Touch
MAXEMS
MAXTENS
EvaQMax
MAXIF
Ultima5
CABLE, ELECTRODE
PROPLATE
PROEMG
PROEEG
PRONEO
PROPENCIL
PROTAB
Establishment Types
Manufacture Medical Device