Identity
- Trade Name
- FlowMIR Disposable Turbine EUDAMEDMIR FDA UDI
- Generic Name
- Expiratory peak flow meter, digital FDA UDI
- Model / Reference
- Spirometry Accessories EUDAMED910004 EUDAMEDFlowMIR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08052990321834 EUDAMEDFDA UDI
- Basic UDI-DI
- 805299032TRB-RUJ7 EUDAMED
- FDA Product Code
- BYP FDA UDI
- EMDN Code
- Z12150180 SPIROMETRY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Expiratory peak flow meter, digital FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5620 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Expiratory peak flow meter, digital
Mir by Mir Medical International Research — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Expiratory peak flow meter, digital.
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Spirolab — MIR - Medical International Research S.p.A. · Class IIa
- Spirolab Plus — MIR - Medical International Research S.p.A. · Class IIa
- NxGen Peak Flow Meter — SAFEY MEDICAL DEVICES PRIVATE LIMITED · Class II
- Spirosound — Medset Medizintechnik GmbH · Class IIa
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mir Medical International Research
Sources (2)
- FDA UDI b806856c-df60-47a2-9ac4-a7ce760e1d87 32 fields · synced Jun 18, 2026
- EUDAMED 96282720-1416-49c6-9ffd-38a2a3702f94 61 fields · synced Jun 18, 2026