FDA Registration
Active
🇺🇸 United States
MIRA, INC.
Reg #: 1218813
·
FEI: 1218813
·
Expires 2026
Products
4
Proprietary Names
16
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- MIRA, INC.
- Registration Number
- 1218813
- FEI Number
- 1218813
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 414 Quaker Hwy
- City
- UXBRIDGE
- State
- MA
- ZIP
- 01569
- Country
- US
Regulatory Submissions
- 510(k) Number
- K923629
Owner / Operator
- Firm Name
- MIRA, INC.
- Operator Number
- 1218813
- Address
- 414 QUAKER HIGHWAY, --
- City
- Uxbridge
- State
- MA
- Postal Code
- 01569
- Country
- US
- Correspondent
- Charles A Schepens
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Cryophthalmic | HPS | Class 2 | Ophthalmic | No | 2007-11-03 |
| Implant, Orbital, Extra-Ocular | HQX | Class 2 | Ophthalmic | No | 2007-11-03 |
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2007-11-03 |
| Implant, Absorbable, (Scleral Buckling Methods) | HQJ | Class 2 | Ophthalmic | No | 2007-11-03 |
Proprietary Names
CR4095
IMEX Scleral Buckling Device, Ophthalmic
CR4085
CR4015
CR4045
CR4023
CR4025
CR4080
CR4090
CR4040
CR4075
CR4000
CR4030
CR4010
CR4022
IMEX Tantalum Clip, Ophthalmic
Establishment Types
Manufacture Medical Device