Spirobank Smart
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Spirobank Smart EUDAMEDMIR FDA UDI
- Generic Name
- Expiratory peak flow meter, digital FDA UDI
- Device Name
- Spirobank Smart EUDAMEDSmart Spirometer connected to an app available on a smart phone FDA UDI
- Model / Reference
- Smart Family device EUDAMED911105P51 EUDAMEDMIR065 EUDAMED911105B51 911105B50 - 911105P51 - 911105P50 - 911105S51 - 911105S50 EUDAMEDMIR SPIROBANK SMART FDA UDI
- Description
- Smart Spirometer connected to an app available on a smart phone FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08052990321759 EUDAMEDFDA UDI
- Basic UDI-DI
- 805299032065E2 EUDAMED
- Direct Marketing DI
- 08052990321759 EUDAMED
- FDA Product Code
- BZG FDA UDI
- EMDN Code
- Z12150102 PEAK FLOW SPIROMETERS EUDAMED
- GMDN Term
- Expiratory peak flow meter, digital FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1840 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Expiratory peak flow meter, digital
Spirobank Smart by MIR - Medical International Research S.p.A. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805299032065E2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- MIR - Medical International Research S.p.A.
- EUDAMED SRN
- IT-MF-000014026
Sources (3)
- EUDAMED fd709a3f-cc20-4531-a2c6-d39ce386d2f4 61 fields · synced Jun 18, 2026
- FDA UDI ccd36448-a4e5-4d81-bf9a-941cd9ff426a 35 fields · synced May 30, 2026
- EUDAMED b1b86abf-4a44-444d-b08c-ac57f4be24f8 61 fields · synced Jun 18, 2026