Is this your brand? Sign in to claim ownership.
Sign in to claim this brandMEDEXEL CO., LTD.
South Korea·KR-MF-000016654
Last updated September 17, 2026
Information
- Country
- South Korea
- Address
- 252, Geumgwangosan-ro, Geumgwang-myeon, Anseong-si, South Korea
- Website
- medexel.co.kr
- —
- —
- [email protected]
- Phone
- +82-10-5141-7665
- PRRC Contact
- Jun-Taek Seo
- EUDAMED SRN
- KR-MF-000016654
- FDA FEI Number
- 3003589279
- DUNS Number
- 689719789
Catalogue (52)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Autokeeper | Safety Pen Needle 32G x 8mm 100PCS | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 33G x 4mm 100PCS | FDA UDI | Class II | Active |
| TopFine® | TopFine®Insulin Pen Needles 31Gx5mm 100pcs | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 31G x 5mm 100PCS | FDA UDI | Class II | Active |
| TopFine® | TopFine®Insulin Pen Needles 31Gx8mm 100pcs | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 32G x 4mm 100PCS | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 34G x 4mm 100PCS | FDA UDI | Class II | Active |
| WellFine® | WellFine®Insulin Pen Needles 34Gx4mm 100pcs | FDA UDI | Class II | Active |
| TopFine® | TopFine®Insulin Pen Needles 32Gx6mm 100pcs | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 30G x 5mm 100PCS | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 33G x 6mm 100PCS | FDA UDI | Class II | Active |
| TopFine® | TopFine®Insulin Pen Needles 31Gx4mm 100pcs | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 30G x 6mm 100PCS | FDA UDI | Class II | Active |
| WellFine® | WellFine®Insulin Pen Needles 34Gx5mm 100pcs | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 29G x 8mm 100PCS | FDA UDI | Class II | Active |
| TopFine® | TopFine®Insulin Pen Needles 31Gx10mm 100pcs | FDA UDI | Class II | Active |
| WellFine® | WellFine®Insulin Pen Needles 33Gx4mm 100pcs | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 34G x 5mm 100PCS | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 34G x 6mm 100PCS | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 33G x 5mm 100PCS | FDA UDI | Class II | Active |
| TopFine® | TopFine Insulin Pen Needles 31Gx6mm 100pcs | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 33G x 8mm 100PCS | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 29G x 6mm 100PCS | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 34G x 8mm 100PCS | FDA UDI | Class II | Active |
| TopFine® | TopFine®Insulin Pen Needles 29Gx12.7mm 100pcs | FDA UDI | Class II | Active |
| TopFine® | TopFine®Insulin Pen Needles 30Gx8mm 100pcs | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 29G x 5mm 100PCS | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 29G x 8mm 100PCS | FDA UDI | Class II | Active |
| TopFine® | TopFine®Insulin Pen Needles 32Gx5mm 100pcs | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 31G x 4mm 100PCS | FDA UDI | Class II | Active |
| WellFine® | WellFine®Insulin Pen Needles 29Gx12.7mm 100pcs | FDA UDI | Class II | Active |
| WellFine® | WellFine®Insulin Pen Needles 32Gx5mm 100pcs | FDA UDI | Class II | Active |
| WellFine® | WellFine®Insulin Pen Needles 33Gx5mm 100pcs | FDA UDI | Class II | Active |
| TopFine® | TopFine®Insulin Pen Needles 34Gx4mm 100pcs | FDA UDI | Class II | Active |
| TopFine® | TopFine®Insulin Pen Needles 34Gx5mm 100pcs | FDA UDI | Class II | Active |
| WellFine® | WellFine®Insulin Pen Needles 31Gx6mm 100pcs | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 32G x 5mm 100PCS | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 31G x 8mm 100PCS | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 32G x 6mm 100PCS | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 30G x 8mm 100PCS | FDA UDI | Class II | Active |
| TopFine® | TopFine®Insulin Pen Needles 33Gx4mm 100pcs | FDA UDI | Class II | Active |
| WellFine® | WellFine®Insulin Pen Needles 32Gx4mm 100pcs | FDA UDI | Class II | Active |
| TopFine® | TopFine®Insulin Pen Needles 33Gx5mm 100pcs | FDA UDI | Class II | Active |
| Autokeeper | Safety Pen Needle 29G x 4mm 100PCS | FDA UDI | Class II | Active |
| WellFine® | WellFine®Insulin Pen Needles 31Gx5mm 100pcs | FDA UDI | Class II | Active |
| WellFine® | WellFine®Insulin Pen Needles 32Gx6mm 100pcs | FDA UDI | Class II | Active |
| WellFine® | WellFine®Insulin Pen Needles 30Gx8mm 100pcs | FDA UDI | Class II | Active |
| WellFine® | WellFine®Insulin Pen Needles 31Gx8mm 100pcs | EUDAMEDFDA UDI | Class II | Active |
| Top Fine Pen Needle | K152410 | FDA 510(k) | Class II | Active |
| TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) | K231856 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.