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US
Last updated May 23, 2026
What ANDESFIT LIMITED makes
Andesfit Limited manufactures non-portable electronic blood pressure monitors that automatically inflate cuffs, pulse oximeters for measuring oxygen saturation, and infrared thermometers for ear and skin temperature readings. Their portfolio also includes professional-grade diagnostic spirometers for lung function testing and home-use glucose monitoring systems classified as in vitro diagnostics. Additionally, they produce bioelectrical impedance analysers to assess body composition metrics like muscle mass and fat percentage.
All listed devices fall under Class II regulatory classification in the US, with each product authorised through the FDA’s Unique Device Identification (UDI) system. The manufacturer operates under US jurisdiction, ensuring compliance with domestic medical device regulations. No devices are listed under international registries such as the EU’s MDR or other global databases.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 664101036
Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Andnesfit Health | ADF-B05 | FDA UDI | Class II | Active |
| Andnesfit Health | ADF-B06 | FDA UDI | Class II | Active |
| Andesfit | ADF-B61 | FDA UDI | Class II | Active |
| Andesfit | ADF-B38A | FDA UDI | Class II | Active |
| Andesfit | ADF-MSA100 | FDA UDI | Class II | Active |
| Andesfit | ADF-B19 | FDA UDI | Class II | Active |
| Andnesfit Health | ADF-B27GTS | FDA UDI | Class II | Active |
| Andnesfit Health | ADF-B27 | FDA UDI | Class II | Active |
| Andnesfit Health | ADF-B05 | FDA UDI | Class II | Active |
| Andnesfit Health | ADF-B19 | FDA UDI | Class II | Active |
| Andnesfit Health | ADF-B27 | FDA UDI | Class II | Active |
| Andnesfit Health | ADF-B38A | FDA UDI | Class II | Active |
| Andnesfit Health | ADF-B885T | FDA UDI | Class II | Active |
| Andnesfit Health | ADF-B34A | FDA UDI | Class II | Active |
| Andnesfit Health | ADF-34A | FDA UDI | Class II | Active |
| Andnesfit Health | ADF-B885T | FDA UDI | Class II | Active |
| Andnesfit Health | ADF-MSA100 | FDA UDI | Class II | Active |
| Andesfit | ADF-B06 | FDA UDI | Class II | Active |
| Andesfit | ADF-B102W | FDA UDI | Class II | Active |
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