FDA Registration
Active
🇰🇷 South Korea
PRIME MEDICAL, INC.
Reg #: 3004579179
·
FEI: 3004579179
·
Expires 2026
Products
6
Proprietary Names
11
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- PRIME MEDICAL, INC.
- Registration Number
- 3004579179
- FEI Number
- 3004579179
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 335 Namyang-ro, Namyang-eup
- City
- HWASEONG-SI Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- PRIME MEDICAL, INC.
- Operator Number
- 9063831
- Address
- 335 Namyang-ro, Namyang-eup, --
- City
- HWASEONG-SHI
- State
- Gyeonggi
- Postal Code
- 18269
- Country
- KR
- Correspondent
- Hugh Jeong Chang
US Agent
- Business Name
- Dawa Medical
- Contact Name
- Stephan Toupin
- Address
- 7320 Nw 12th St Ste 103
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 786 7311159
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2019-02-04 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2005-09-20 |
| Instrument, Cast Removal, Ac-Powered | LGH | Class 1 | Orthopedic | No | 2011-12-12 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2019-02-04 |
| Tape, Orthopedic | HXT | Class 1 | General, Plastic Surgery | No | 2005-03-15 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2004-05-28 |
Proprietary Names
PrimeNet DRY
PrimeCOB
PrimePad
PrimeNet
PrimeCrepe
PrimeFix
PrimeCutter
PrimeSling
PrimePOP Premium
PrimeSoft
PrimeCast
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)