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US
Last updated May 30, 2026
What SIMPRO makes
The company manufactures line-powered pulse oximeters for monitoring oxygen saturation and portable, automatic-inflation electronic sphygmomanometers designed for finger use. It also produces foetal Doppler systems for prenatal monitoring and additional pulse oximeters. These devices are intended for clinical and home-use applications.
The portfolio consists of Class II medical devices, all of which are listed in the FDA’s Udimplist (UDI) database. The company operates from the United States, adhering to applicable regulatory requirements for these device classifications.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does SIMPRO manufacture?
SIMPRO manufactures a range of Class II medical devices, including line-powered pulse oximeters for monitoring oxygen saturation levels, portable automatic-inflation electronic sphygmomanometers designed for finger use, and foetal Doppler systems for prenatal monitoring. These devices are intended for use in both clinical and home settings.
Where is SIMPRO based, and how does this affect its regulatory compliance?
SIMPRO is based in the United States, which means its devices must comply with FDA regulations. Since all its products fall under Class II classification, they are subject to the FDA’s requirements for these categories, including mandatory listing in the FDA’s Udimplist (UDI) database to ensure traceability and regulatory oversight.
Are SIMPRO’s devices listed in any regulatory registries, and why does this matter?
Yes, SIMPRO’s devices are listed in the FDA’s Udimplist (UDI) database. This matters because the UDI system helps ensure device identification, tracking, and transparency throughout the supply chain, supporting patient safety, regulatory compliance, and efficient recall management if needed.
How are SIMPRO’s devices classified by regulatory authorities, and what does this classification imply?
SIMPRO’s devices are classified as Class II by regulatory authorities. This classification implies that while they pose moderate risk, they still require compliance with specific controls—such as performance standards, post-market surveillance, and registration—to ensure safety and effectiveness without requiring pre-market approval.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- naturespiritproduct.com
- —
- —
- [email protected]
- Phone
- (877) 299-0356
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 188434448
Catalogue (20)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NatureSpirit | CMS-50d | FDA UDI | Class II | Active |
| NatureSpirit | SHO-1002 | FDA UDI | Class II | Active |
| NatureSpirit | Sonoline B | FDA UDI | Class II | Active |
| NatureSpirit | CMS50DL | FDA UDI | Class II | Active |
| NatureSpirit | CMS-50D/CMS-50D1 | FDA UDI | Class II | Active |
| Care Mill | C01 | FDA UDI | Class II | Active |
| Care Mill | CMS-50Q1 TIGER | FDA UDI | Class II | Active |
| NatureSpirit | KD-5904 | FDA UDI | Class II | Active |
| NatureSpirit | CMS-50F | FDA UDI | Class II | Active |
| Care Mill | CMS-50Q1 PIG | FDA UDI | Class II | Active |
| Care Mill | CP-50FBLE | FDA UDI | Class II | Active |
| NatureSpirit | CMS-50dl | FDA UDI | Class II | Active |
| NatureSpirit | CP-500E | FDA UDI | Class II | Active |
| NatureSpirit | CMS-60D | FDA UDI | Class II | Active |
| NatureSpirit | BP-1307 | FDA UDI | Class II | Active |
| Care Mill | CMS-50Q1 HIPPO | FDA UDI | Class II | Active |
| NatureSpirit | CP-50BLE | FDA UDI | Class II | Active |
| Care Mill | Baby Sound C | FDA UDI | Class II | Active |
| Care Mill | CP-500 | FDA UDI | Class II | Active |
| NatureSpirit | CMS-50E | FDA UDI | Class II | Active |
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