FDA Registration
Active
🇹🇼 Taiwan
ACULA TECHNOLOGY CORP
Reg #: 3003032840
·
FEI: 3003032840
·
Expires 2026
Products
3
Proprietary Names
5
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- ACULA TECHNOLOGY CORP
- Registration Number
- 3003032840
- FEI Number
- 3003032840
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| System, Reading, Television, Closed-Circuit | HJG | Class 1 | Ophthalmic | No | 2010-03-30 |
| Display, Diagnostic Radiology | PGY | Class 2 | Radiology | No | 2024-10-24 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2026-04-16 |
Proprietary Names
LUMIN UMD5-21B01
ME2-24B23
ME1-19A01
ME2-24A01
LUMIN UMD3-21B01
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device