FDA Registration
Active
🇹🇼 Taiwan
Yushan Flat Panel Detector with DROC
Reg #: 3015531968
·
FEI: 3015531968
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INNOCARE OPTOELECTRONICS CORP.
- Registration Number
- 3015531968
- FEI Number
- 3015531968
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Rm. B, No. 2, Sec. 2, Huanxi Rd., Southern Taiwan Science Park, Xinshi Dist., Tainan City 741, Taiwan, R.O.C.
- City
- Tainan
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K201528
Owner / Operator
- Firm Name
- InnoCare Optoelectronics Corp.
- Operator Number
- 10060738
- Address
- Rm. B, No. 2, Sec. 2, Huanxi Rd., Southern Taiwan Science Park, Xinshi Dist., Tainan City 741, Taiwan, R.O.C.
- City
- Tainan
- State
- TW-TNN
- Postal Code
- 741
- Country
- TW
- Correspondent
- Eason Tsai
US Agent
- Business Name
- InnoCare Optoelectonics USA, Inc
- Contact Name
- JUNICHI ISHII
- Address
- 101 METRO DRIVE SUITE 365
- City
- San Jose
- State
- CA
- ZIP
- 95110
- Country
- US
- [email protected]
- Phone
- 408 5738438 ext. 100
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2020-10-29 |
Proprietary Names
Yushan Flat Panel Detector with DROC
ENDURO DR
Establishment Types
Manufacture Medical Device