FDA Registration
Active
🇮🇹 Italy
MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A.
Reg #: 9614860
·
FEI: 3004612204
·
Expires 2026
Products
4
Proprietary Names
24
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A.
- Registration Number
- 9614860
- FEI Number
- 3004612204
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Viale Luigi Schiavonetti, 270
- City
- ROMA
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K181666
Owner / Operator
- Firm Name
- MIR MEDICAL INTL. RESEARCH S.P.A.
- Operator Number
- 9034107
- Address
- Viale Luigi Schiavonetti 270, --
- City
- ROMA
- State
- Lazio
- Postal Code
- 00173
- Country
- IT
- Correspondent
- Giulia - Maiorana
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Meter, Peak Flow, Spirometry | BZH | Class 2 | Anesthesiology | No | 2018-11-16 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2014-01-10 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2014-01-10 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2024-01-25 |
Proprietary Names
Smart One
Cohero - cSpirometer
Spirotel
Smart One Oxi
AsthmaTuner
Spirobank Smart
Spirobank Oxi
Cohero - mSpirometer
Spirobank II
Spirobank II PLUS
Spirobank II Light
Minispir
Spirolab III
Spirolab PLUS
Spirolab
Minispir PLUS
Spirolab PLUS ESI
Minispir PLUS ESI
Spirodoc
Nuvoair
FlowMIR
Reusable Turbine Plus
FlowMIR Plus
spirobank G
Establishment Types
Manufacture Medical Device