FDA Registration
Active
🇰🇷 South Korea
DIMEDI KOREA INC
Reg #: 3029913483
·
FEI: 3029913483
·
Expires 2026
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
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Registration Details
- Registration Name
- DIMEDI KOREA INC
- Registration Number
- 3029913483
- FEI Number
- 3029913483
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rm.201,1 Mandeok 3-ro 16beon-gil, Buk-gu, Busan
- City
- Busan
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K232238
Owner / Operator
- Firm Name
- DIMEDI KOREA INC
- Operator Number
- 10094323
- Address
- Rm.201,1 Mandeok 3-ro 16beon-gil, Buk-gu, Busan
- City
- Busan
- State
- KR-26
- Postal Code
- 46570
- Country
- KR
- Correspondent
- DONGHUN LEE
US Agent
- Business Name
- SMB USA LLC.
- Contact Name
- HUICHAO LEE
- Address
- 44855 Lafayette Dr
- City
- Novi
- State
- MI
- ZIP
- 48377
- Country
- US
- [email protected]
- Phone
- 734 6297552
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mouthguard, Over-The-Counter | OBR | Class U | Unknown | No | 2025-11-23 |
Proprietary Names
GOYO SLIM FIT MOUTH GUARD
GOYO Mouthpiece S
Establishment Types
Manufacture Medical Device