FDA Registration
Active
🇰🇷 South Korea
NISCHEM MEDICAL CO., LTD.
Reg #: 3007842664
·
FEI: 3007842664
·
Expires 2026
Products
3
Proprietary Names
6
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- NISCHEM MEDICAL CO., LTD.
- Registration Number
- 3007842664
- FEI Number
- 3007842664
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 503-19, Jimun-ro, Wongok-myeon
- City
- Anseong-si Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- NISCHEM MEDICAL CO., LTD.
- Operator Number
- 10043872
- Address
- 503-19, Jimun-ro, Wongok-myeon,
- City
- Anseong-si
- State
- Gyeonggi
- Postal Code
- 17554
- Country
- KR
- Correspondent
- Chul Hong Kim
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- Priscilla Chung
- Address
- 2552 Walnut Ave Ste 230
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
- [email protected]
- Phone
- 714 9225276
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2022-12-26 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2025-02-14 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2022-12-26 |
Proprietary Names
Bioabsorbable ACL screw
Fix2Lock(Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
Suture Wing
Fix2Lock (PEEK Self Punching)
LUTRONIC GENIUS
INFINI RADIOFREQUENCY SYSTEM
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)