FDA Registration
Active
🇹🇼 Taiwan
ZSP2105CMI with QUBYX PerfectLum
Reg #: 3007817002
·
FEI: 3007817002
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DIVA LABORATORIES, LTD.
- Registration Number
- 3007817002
- FEI Number
- 3007817002
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9F. NO.351, SEC.2 ZHONGSHAN ROAD, ZHONGHE DIST.
- City
- NEW TAIPEI CITY, TAIPEI-DISTRICT, 235
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K160328
Owner / Operator
- Firm Name
- DIVA Laboratories, Ltd.
- Operator Number
- 10050307
- Address
- 9F. No.351, Sec.2 Zhongshan Road, Zhonghe Dist.
- City
- New Taipei City
- State
- TW-TPE
- Postal Code
- 235
- Country
- TW
- Correspondent
- Rongchi Liao
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Display, Diagnostic Radiology | PGY | Class 2 | Radiology | No | 2024-12-03 |
Proprietary Names
ZSP2105CMI with QUBYX PerfectLum
Establishment Types
Manufacture Medical Device