FDA Registration
Active
🇰🇷 South Korea
Medifirst Co.,Ltd.
Reg #: 3010384323
·
FEI: 3010384323
·
Expires 2026
Products
5
Proprietary Names
13
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- Medifirst Co.,Ltd.
- Registration Number
- 3010384323
- FEI Number
- 3010384323
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1049-16, Charyeonggogae-ro, Gwangdeok-myeon, Dongnam-gu,
- City
- Cheonan-si, Chungnam
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K080904
Owner / Operator
- Firm Name
- MediFirst Co.,Ltd.
- Operator Number
- 10043739
- Address
- 1049-16, Charyeonggogae-ro,, Gwangdeok-myeon, Dongnam-gu,
- City
- Cheonan-si,
- State
- Chungnam
- Postal Code
- 330922
- Country
- KR
- Correspondent
- Young Ju Lee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2013-03-18 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-09-17 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2020-05-18 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2020-08-30 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2013-03-18 |
Proprietary Names
Feel Fine Insulin pen needle
ESR GRAPHENE MARATHON Face Mask/MF-KIP-007(L), MF-KIP-008(M), MF-KIP-009(S)
RED SHIELD Face Mask(KF-AD)/MF-KFAD-001(L), MF-KFAD-002(M), MF-KFAD-003(S)
RED SHIELD Face Mask(KF-80)/MF-KF80-001(L), MF-KF80-002(M), MF-KF80-003(S)
RED SHIELD Face Mask(KF94)/MF-KF94-001(L), MF-KF94-002(M), MF-KF94-003(S)
WOOA Face Mask(KF80)/MF-KF80-004(L), MF-KF80-005(M), MF-KF80-006(S)
WOOA Face Mask(KF-AD)/MF-KFAD-004(L), MF-KFAD-005(M), MF-KFAD-006(S)
MEDI HIT Face Mask/MF-KFAD-007(L), MF-KFAD-008(M), MF-KFAD-009(S)
WOOA Face Mask(KF94)/MF-KF94-004(L), MF-KF94-005(M), MF-KF94-006(S)
MEDI HIT Face Mask(KF94)/MF-KF94-007(L), MF-KF94-008(M), MF-KF94-009(S)
MF SAFECATH
MF Reagents (MF C001, MF C002, MF C003, MF C004, MF C005)
Feel-Ject Insulin syringe
Establishment Types
Manufacture Medical Device