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Sign in to claim this brandCleveland Medical Devices Inc.
US
Last updated May 24, 2026
What Cleveland Medical Devices Inc. makes
Cleveland Medical Devices Inc. makes electroencephalograph devices, including the Premium Study Kit, SleepView Starter Kit, Sapphire, SleepView, ReadyRip Belt, and Sapphire PSG 2400 Starter Kit.
These devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) and FDA UDI registries; the company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of devices does Cleveland Medical Devices Inc. manufacture?
Cleveland Medical Devices Inc. manufactures electroencephalograph devices, as indicated in the device categories and summary. Examples include the Premium Study Kit, SleepView Starter Kit, Sapphire, SleepView, ReadyRip Belt, and Sapphire PSG 2400 Starter Kit. These are the specific devices listed in the provided data, and no other products or device types are mentioned.
Where is Cleveland Medical Devices Inc. based?
Cleveland Medical Devices Inc. is based in the United States, as explicitly stated in the COUNTRY field and reiterated in the SUMMARY. The data does not provide a specific city or state, only the country of origin.
In which regulatory registries are Cleveland Medical Devices Inc.'s devices listed?
The devices manufactured by Cleveland Medical Devices Inc. are listed in the FDA 510(k) and FDA UDI registries, as specified in the LISTED IN field. This indicates that the devices have been submitted for premarket notification under 510(k) and are included in the Unique Device Identification system, but does not imply approval or clearance of the company itself.
How are Cleveland Medical Devices Inc.'s devices classified?
Cleveland Medical Devices Inc.'s devices are classified as Class I and Class II medical devices, as stated in the DEVICE CLASSES field. This classification reflects the risk level and regulatory controls applicable to the devices, with Class I being low risk and Class II requiring special controls. The classification applies to the devices, not the company.
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
- 557510625
Catalogue (42)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Premium Study Kit | Extra Large - Single | FDA UDI | Class II | Active |
| SleepScout | International Sensor Kit | FDA UDI | Class II | Unknown |
| SleepView Starter Kit | Premium Rental Starter Kit | FDA UDI | Class II | Active |
| Sapphire | LifeSense to Sapphire Serial Cable | FDA UDI | Class II | Active |
| SleepView | SleepView II | FDA UDI | Class II | Active |
| SleepScout | Computer Unit | FDA UDI | Class II | Unknown |
| Premium Study Kit | Two Belt - XLarge | FDA UDI | Class II | Active |
| ReadyRip Belt | Large - Single | FDA UDI | Class II | Active |
| Sapphire | Sensor Kit | FDA UDI | Class II | Active |
| Premium Study Kit | Proact - Single | FDA UDI | Class II | Active |
| Premium Study Kit | Two Belt - Large | FDA UDI | Class II | Active |
| Study Kit | Single | FDA UDI | Class II | Active |
| Sapphire | XPOD Interface | FDA UDI | Class II | Active |
| Sapphire PSG 2400 Starter Kit | Standard | FDA UDI | Class II | Active |
| Study Kit | International - Single | FDA UDI | Class II | Active |
| SleepView Starter Kit | Consignment | FDA UDI | Class II | Active |
| Premium Study Kit | Two Belt - XXLarge | FDA UDI | Class II | Active |
| Premium Study Kit | Large - Single | FDA UDI | Class II | Active |
| ReadyRip Belt | Extra Extra Large - Single | FDA UDI | Class II | Active |
| SleepScout | SleepScout Mobile Unit | FDA UDI | Class II | Unknown |
| SleepView | SleepView Starter Kit | FDA UDI | Class II | Active |
| SleepScout | Optional Sensor Kit | FDA UDI | Class II | Unknown |
| Premium Study Kit | Extra Extra Large - Single | FDA UDI | Class II | Active |
| SleepView RIP Belt Interface | SleepView | FDA UDI | Class II | Active |
| SleepScout Starter Kit | Standard | FDA UDI | Class II | Unknown |
| SleepScout | Computer Unit | FDA UDI | Class II | Unknown |
| SleepView Starter Kit | ProAct SleepView Starter Kit | FDA UDI | Class II | Active |
| SleepScout | XPOD Interface | FDA UDI | Class II | Unknown |
| ReadyRip Belt | Extra Large - Single | FDA UDI | Class II | Active |
| Sapphire | Sapphire 2400 Patient Unit | FDA UDI | Class II | Active |
| ReadyRip Belt | Small - Single | FDA UDI | Class II | Active |
| Study Kit | Compatible with Thermistor - Single | FDA UDI | Class II | Active |
| ReadyRip Belt | Medium - Single | FDA UDI | Class II | Active |
| SleepView Starter Kit | International | FDA UDI | Class II | Active |
| Crystal-Eeg Model 15 | K001110 | FDA 510(k) | Class II | Active |
| Liberty Valve | K964690 | FDA 510(k) | Class II | Active |
| Kinesia | K063872 | FDA 510(k) | Class II | Active |
| Crystal Monitor Model 16 | K013863 | FDA 510(k) | Class II | Active |
| Crystal-Eeg Model 10 (model 10) | K970672 | FDA 510(k) | Class II | Active |
| Pressore Monitor | K954670 | FDA 510(k) | Class I | Active |
| Family Of Crystal 20 Monitors Model #cs20-600, 900, 1300, 1400, 2400 & 120 | K042039 | FDA 510(k) | Class II | Active |
| Foot Weight Alarm | K962591 | FDA 510(k) | Class II | Active |
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