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Sign in to claim this brandBresotec, Inc.
US
Last updated May 30, 2026
What Bresotec, Inc. makes
Bresotec, Inc. manufactures home-use sleep apnoea recording systems, including the BresoDX1 Master Kit, BresoDX1 Accessory Kit, and various components such as the BresoDX1 BresoSensor, Tape Strips, BresoSensor Frame, and BresoHub.
The company's devices are classified as Class II and are listed in the FDA 510(k) and FDA UDI registries. Bresotec is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What type of devices does Bresotec, Inc. manufacture?
Bresotec, Inc. manufactures home-use sleep apnoea recording systems, including various kits and components, as these are listed in the company's device categories and example devices.
Where is Bresotec, Inc. based?
Bresotec, Inc. is based in the US, as indicated by the company's country information.
Which registries list Bresotec, Inc.'s devices?
Bresotec, Inc.'s devices are listed in the FDA 510(k) and FDA UDI registries, as these are specified as the registries where the company's devices are listed.
How are Bresotec, Inc.'s devices classified?
Bresotec, Inc.'s devices are classified as Class II, which is a specific classification for medical devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 203297148
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BresoDX1 Accessory Kit | BTSM1-UFBTS | FDA UDI | Class II | Active |
| BresoDX1 Master Kit | BTSM1US | FDA UDI | Class II | Active |
| BresoDX1 BresoSensor | BTSM1US-URU | FDA UDI | Class II | Active |
| BresoDX1 Tape Strips | BTSM1-BTS | FDA UDI | Class II | Active |
| BresoDX1 BresoSensor Frame | BTSM1-UF | FDA UDI | Class II | Active |
| BresoDX1BresoHub | BTSM1US-DCU | FDA UDI | Class II | Active |
| BresoDX1 Main Kit | BTSM1US-DCUURU | FDA UDI | Class II | Active |
| BresoDX1 | K220012 | FDA 510(k) | Class II | Active |
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