FDA Registration
Active
🇰🇷 South Korea
BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE
Reg #: 3012502601
·
FEI: 3012502601
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HI MEDICAL CO., LTD.
- Registration Number
- 3012502601
- FEI Number
- 3012502601
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- B-2005, 583, YANGCHEON-RO , GANGSEO-GU,
- City
- SEOUL
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K041071
Owner / Operator
- Firm Name
- HI MEDICAL CO., LTD.
- Operator Number
- 10052106
- Address
- B-2005, 583, YANGCHEON-RO , GANGSEO-GU,
- City
- SEOUL
- State
- KR-11
- Postal Code
- 07547
- Country
- KR
- Correspondent
- SEONG IL CHOI
US Agent
- Business Name
- SKY EAGLE LOGISTICS. INC
- Contact Name
- MYEONGHO HA
- Address
- 247 E REDONDO BEACH BLVD, GARDENA, CA, 90248
- City
- Gardena
- State
- CA
- ZIP
- 90248
- Country
- US
- [email protected]
- Phone
- 310 3230161
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2021-04-25 |
Proprietary Names
BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE
Establishment Types
Export Device to the United States But Perform No Other Operation on Device