MIR
Portable spirometer for lung function testing with oximetry function with reusable turbine
10manufacturers in China registered for this device type
56catalogue numbers in this listing
9510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Fujian (1). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| GVS Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Flexible Circuit Technologies Shenzhen | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Feellife Health Inc. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Mir Medical International Research, Italy |
|---|---|
| FDA product code | BZG |
| Device type | Spirometer, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1840 |
| 510(k) | K122384 |
| Record published | 2026-04-03 |
| Record revised | 2024-11-22 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Spirolab PLUS | In distribution | |
| Spirobank II PLUS | In distribution | |
| MiniSpir PLUS | In distribution | |
| Spirolab New spirometer + oximeter | In distribution | |
| Spirolab New spirometer Light | In distribution | |
| Spirobank II PLUS | In distribution | |
| MIR SPIROTEL SPIROMETER BASIC | In distribution | |
| Spirobank Oxi | In distribution | |
| MiniSpir PLUS | In distribution | |
| Spirobank II PLUS | In distribution | |
| Spirolab PLUS ESI | In distribution | |
| MiniSpir PLUS ESI | In distribution | |
| Spirolab PLUS | In distribution | |
| Spirobank II PLUS | In distribution | |
| Spirobank II PLUS | In distribution | |
| MIR SPIROBANK SMART | In distribution | |
| Spirolab PLUS ESI | In distribution | |
| MIR SPIROTEL SPIROMETER | In distribution | |
| MIR Spirobank II New spirometer | In distribution | |
| MiniSpir PLUS ESI | In distribution | |
| MIR SPIROTEL SPIROMETER WITH BLUETOOTH | In distribution | |
| MIR Spirobank II New Basic | In distribution | |
| Spirolab New spirometer Light Bluetooth | In distribution | |
| Spirobank II Light | In distribution | |
| MIR Spirobank II New spirometer and oximeter | In distribution | |
| MIR Spirobank II New BLE spirometer | In distribution | |
| Spirolab PLUS ESI | In distribution | |
| Smart One Oxi | In distribution | |
| MiniSpir PLUS ESI | In distribution | |
| Spirolab PLUS | In distribution | |
| MIR SPIROBANK SMART | In distribution | |
| Spirolab PLUS ESI | In distribution | |
| Spirobank II Light | In distribution | |
| Spirolab New spirometer | In distribution | |
| Spirobank II PLUS | In distribution | |
| Spirobank II PLUS | In distribution | |
| MiniSpir PLUS | In distribution | |
| MiniSpir spirometer Light POST BD Edition | In distribution | |
| MIR Spirobank II New Basic | In distribution | |
| Spirolab PLUS ESI | In distribution | |
| AsthmaTuner | In distribution | |
| Spirolab PLUS ESI | In distribution | |
| Spirobank II PLUS | In distribution | |
| MIR SPIROTEL SPIROMETER WITH OXIMETRY | In distribution | |
| Spirolab PLUS | In distribution | |
| MiniSpir PLUS | In distribution | |
| Spirolab PLUS | In distribution | |
| Spirolab PLUS ESI | In distribution | |
| Spirolab PLUS | In distribution | |
| Spirolab PLUS | In distribution | |
| Spirolab PLUS | In distribution | |
| MiniSpir PLUS ESI | In distribution | |
| Spirolab PLUS ESI | In distribution | |
| Spirobank II Light | In distribution | |
| MiniSpir spirometer with cable | In distribution | |
| Spirobank II Light | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Polytech Filter | Polytechnic Resources, Inc. | 190 |
| Model 4000 | Vitalograph Ireland Ltd. | 115 |
| Astra Spirometer | S D I Diagnostics Inc | 90 |
| Curaplex | TRI-Anim Health Services, Inc. | 55 |
| Alpha | Vitalograph Ireland Ltd. | 48 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 47 |
| MGC Diagnostics | Medical Graphics Corp. | 42 |
| Astraguard | S D I Diagnostics Inc | 39 |
| PFT | Vitalograph Ireland Ltd. | 38 |
| Vyaire | Jaeger Medical GmbH | 36 |
| BVF | Vitalograph Ireland Ltd. | 29 |
| Micro Medical | Jaeger Medical GmbH | 25 |
Showing 12 of 123. All products under Spirometer, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130784 | 2013-10-30 |
| K122384 | 2012-10-04 |
| K082766 | 2008-12-17 |
| K072979 | 2007-12-26 |
| K061875 | 2006-12-11 |
| K061712 | 2006-12-01 |
| K052140 | 2006-03-16 |
| K043528 | 2005-07-19 |
| K983909 | 1998-12-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.