FDA Registration
Active
🇰🇷 South Korea
OPENCAST (Model name: SA-S, SA-M, CM-03, CM-04, CM-05, CM-06, CM-06, CM-07, CM-08)
Reg #: 3025306483
·
FEI: 3025306483
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OPENM INC.
- Registration Number
- 3025306483
- FEI Number
- 3025306483
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 413, Expo-ro
- City
- Yuseong-gu Daejeon
- Country
- KR
Owner / Operator
- Firm Name
- openM inc.
- Operator Number
- 10086632
- Address
- 413, Expo-ro
- City
- Yuseong-gu
- State
- Daejeon
- Postal Code
- 34051
- Country
- KR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2022-11-28 |
Proprietary Names
OPENCAST (Model name: SA-S, SA-M, CM-03, CM-04, CM-05, CM-06, CM-06, CM-07, CM-08)
Establishment Types
Manufacture Medical Device