FDA Registration
Active
🇰🇷 South Korea
S-Patch Ex
Reg #: 3029915537
·
FEI: 3029915537
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- WELLYSIS CORP.
- Registration Number
- 3029915537
- FEI Number
- 3029915537
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8F, 425 Teheran-ro,
- City
- Gangnam-gu, Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K231289
Owner / Operator
- Firm Name
- Wellysis Corp.
- Operator Number
- 10088983
- Address
- 8F, 425 Teheran-ro,
- City
- Gangnam-gu,
- State
- Seoul
- Postal Code
- 06159
- Country
- KR
- Correspondent
- Young Juhn
US Agent
- Business Name
- Wellysis USA Inc.
- Contact Name
- Dennis Ahn
- Address
- 2450 Holcombe Blvd Ste J
- City
- Houston
- State
- TX
- ZIP
- 77021
- Country
- US
- [email protected]
- Phone
- 217 2986850
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Recorder, Magnetic Tape, Medical | DSH | Class 2 | Cardiovascular | No | 2023-10-26 |
Proprietary Names
S-Patch Ex
Establishment Types
Manufacture Medical Device