Mir
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Spirodoc EUDAMEDMIR FDA UDI
- Generic Name
- Expiratory peak flow meter, digital FDA UDI
- Device Name
- Portable oximeter FDA UDI
- Model / Reference
- MIR040 EUDAMED910606 - 910606E - 910606I EUDAMEDMIR SPIRODOC OXIMETER FDA UDI
- Description
- Portable oximeter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08052990320356 EUDAMEDFDA UDI
- Basic UDI-DI
- 805299032040O48 EUDAMED
- 510(k) Number
- K103530 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
- GMDN Term
- Expiratory peak flow meter, digital FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 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
K103530 also covers:
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 |
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Manufacturer
- Manufacturer
- Mir Medical International Research
Sources (2)
- FDA UDI 04f09d30-3fd3-47b5-b4e1-61db3c2737f2 35 fields · synced Jul 8, 2026
- EUDAMED 0d0a54f9-4343-41ce-af43-82ae24df9b7b 61 fields · synced Jun 18, 2026