FDA Registration
Active
🇺🇸 United States
RAICO
Reg #: 3015528097
·
FEI: 3015528097
·
Expires 2026
Products
5
Proprietary Names
4
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- RAICO
- Registration Number
- 3015528097
- FEI Number
- 3015528097
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 825 North Cass Avenue, 202
- City
- Westmont
- State
- IL
- ZIP
- 60559
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192418
Owner / Operator
- Firm Name
- RAICO
- Operator Number
- 10060634
- Address
- 825 N Cass Ave, Suite 202
- City
- Westmont
- State
- IL
- Postal Code
- 60559
- Country
- US
- Correspondent
- Ravi Nallakrishnan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2020-05-27 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2021-01-23 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2020-06-15 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2021-01-23 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2019-06-04 |
Proprietary Names
HARMONIX Phaco tips
RAICO Trabeculotomy Instruments
HARMONIX Polymer IA tips
iVEnT System ; Tanito GCS ; Espaillat JCS ; Gonio Scrub
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device