Mir
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Spirobank II with Bluetooth Smart EUDAMEDMIR FDA UDI
- Generic Name
- Expiratory peak flow meter, digital FDA UDI
- Device Name
- Portable spirometer and oximeter for lung function testing with Bluetooth smart technology FDA UDI
- Model / Reference
- MIR059 EUDAMED911029 - 911029T - 911029E0 - 911029E1 - 911029I0 - 911029I1 EUDAMEDMIR Spirobank II New BLE spiro & oxy FDA UDI
- Description
- Portable spirometer and oximeter for lung function testing with Bluetooth smart technology FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08052990320950 EUDAMEDFDA UDI
- Basic UDI-DI
- 805299032056-059EU EUDAMED
- 510(k) Number
- K061712 FDA UDI
- FDA Product Code
- DQA FDA UDIBZG 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
- 870.2700 FDA UDI868.1840 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
Mir by Mir Medical International Research — Class II — 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
Cleared under the same submission
K061712 also covers:
- MIR — Mir Medical International Research
- MIR — Mir Medical International Research
- MIR — Mir Medical International Research
- MIR — Mir Medical International Research
- MIR — Mir Medical International Research
- MIR — Mir Medical International Research
- MIR — Mir Medical International Research
- MIR — Mir Medical International Research
- MIR — Mir Medical International Research
- MIR — Mir Medical International Research
- MIR — Mir Medical International Research
- MIR — Mir Medical International Research
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mir Medical International Research
Sources (2)
- FDA UDI 77b12a2d-f0c5-4690-bd12-8acfd7eb0c99 35 fields · synced Jun 19, 2026
- EUDAMED 2e0d4d51-c52e-4e97-b97a-67e3239f40e8 61 fields · synced Jun 19, 2026