FDA Registration
Active
🇹🇼 Taiwan
LUMIN UMD5-21B01
Reg #: 3003032840
·
FEI: 3003032840
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ACULA TECHNOLOGY CORP
- Registration Number
- 3003032840
- FEI Number
- 3003032840
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11, Alley 21, Lane 20, Dashing Rd.,, Luchu Dist., Taoyuan City, Taiwan
- City
- Luchu Taoyuan
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K241499
Owner / Operator
- Firm Name
- ACULA TECHNOLOGY CORP.
- Operator Number
- 10032010
- Address
- 11, Alley 21, Lane 20, Dashing Rd.,, Luchu Dist., Taoyuan City, Taiwan
- City
- Luchu
- State
- Taoyuan
- Postal Code
- 33862
- Country
- TW
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Display, Diagnostic Radiology | PGY | Class 2 | Radiology | No | 2024-10-24 |
Proprietary Names
LUMIN UMD5-21B01
Establishment Types
Manufacture Medical Device