FDA Registration
Active
🇹🇼 Taiwan
BL-Cart IOL Delivery Cartridge
Reg #: 3009646326
·
FEI: 3009646326
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ICARES MEDICUS, INC.
- Registration Number
- 3009646326
- FEI Number
- 3009646326
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4F, No.16, Sec. 2, Sheng Yi Road., Zhubei, Hsinchu 30261 Taiwan, R.O.C.
- City
- Zhubei Hsinchu
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K182965
Owner / Operator
- Firm Name
- ICARES Medicus, Inc.
- Operator Number
- 10047474
- Address
- 4F, No.16, Sec. 2, Sheng Yi Road., Zhubei, Hsinchu 30261 Taiwan, R.O.C.
- City
- Zhubei
- State
- Hsinchu
- Postal Code
- 30261
- Country
- TW
- Correspondent
- Amanda Lu
US Agent
- Business Name
- AST Products, Inc.
- Contact Name
- William Lee
- Address
- 9 Linnell Cir
- City
- Billerica
- State
- MA
- ZIP
- 01821
- Country
- US
- [email protected]
- Phone
- 978 6674500
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Folders And Injectors, Intraocular Lens (Iol) | MSS | Class 1 | Ophthalmic | No | 2019-10-08 |
Proprietary Names
BL-Cart IOL Delivery Cartridge
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)