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Sign in to claim this brandStat Medical Corp.
US
Last updated May 23, 2026
What Stat Medical Corp. makes
Stat Medical Corp. manufactures sterile cotton pads, stroke slings for patient positioning, flexion mittens for hand rehabilitation, and elbow protectors designed to prevent injury during recovery or mobility assistance.
All products fall under Class I regulatory classification in the U.S. and are listed via 510(k) clearance with the FDA. The company operates from 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 medical devices does Stat Medical Corp. manufacture?
Stat Medical Corp. specializes in Class I medical devices designed for patient care and rehabilitation. Their product line includes sterile cotton pads for wound care, stroke slings for positioning patients during recovery, flexion mittens to aid hand rehabilitation, and elbow protectors to prevent injury during mobility assistance. These devices are intended for use in clinical and home settings.
Where is Stat Medical Corp. based, and how does that affect its regulatory approach?
Stat Medical Corp. is based in the United States. Since the company operates within the U.S. market, its devices are subject to FDA regulations. All listed products fall under Class I classification, which typically involves less stringent premarket review compared to higher-risk classes, but still requires compliance with FDA requirements such as 510(k) clearance for certain devices.
Which regulatory registries or databases list Stat Medical Corp.’s devices?
Stat Medical Corp.’s devices are listed in the FDA’s 510(k) clearance database. This registry confirms that the company’s products, including sterile cotton, stroke slings, flexion mittens, and elbow protectors, have undergone the necessary premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device.
How are Stat Medical Corp.’s devices classified under U.S. regulations?
Stat Medical Corp.’s devices are classified as Class I under U.S. FDA regulations. This classification applies to products that pose minimal risk to patients and users, such as sterile cotton pads, slings, and protective accessories. Class I devices generally require less regulatory oversight, but compliance with good manufacturing practices (GMP) and other applicable standards is still mandatory to ensure safety and effectiveness.
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
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Catalogue (792)
Page 12 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Statcorp Medical | STATCORP | FDA UDI | Class II | Active |
| Unifuser | Unifuser | FDA UDI | Class I | Active |
| Ultracheck | UltraCheck BP Cuffs | FDA UDI | Class II | Active |
| Statcorp Medical | STATCORP | FDA UDI | Class I | Unknown |
| Ultracheck | UltraCheck BP Cuffs | FDA UDI | Class II | Unknown |
| Ultracheck | Ultracheck | FDA UDI | Class II | Active |
| Softcheck | SoftCheck BP Cuffs | FDA UDI | Class II | Active |
| Statcorp Medical | STATCORP | FDA UDI | Class I | Unknown |
| Statcorp Medical | STATCORP | FDA UDI | Class II | Unknown |
| Statcorp Medical | STATCORP | FDA UDI | Class I | Unknown |
| Ultracheck | UltraCheck BP Cuffs | FDA UDI | Class II | Unknown |
| Ultracheck | UltraCheck BP Cuffs | FDA UDI | Class II | Active |
| Softcheck | SoftCheck BP Cuffs | FDA UDI | Class II | Active |
| Ultracheck | UltraCheck BP Cuffs | FDA UDI | Class II | Active |
| Softcheck | SoftCheck BP Cuffs | FDA UDI | Class II | Active |
| Ultracheck | UltraCheck BP Cuffs | FDA UDI | Class II | Active |
| Softcheck | SoftCheck BP Cuffs | FDA UDI | Class II | Active |
| Statcorp Medical | STATCORP | FDA UDI | Class I | Unknown |
| Ultracheck | UltraCheck BP Cuffs | FDA UDI | Class II | Unknown |
| Softcheck | SoftCheck BP Cuffs | FDA UDI | Class II | Active |
| Statcorp Medical | STATCORP | FDA UDI | Class II | Active |
| Ultracheck | UltraCheck BP Cuffs | FDA UDI | Class II | Active |
| Softcheck | SoftCheck BP Cuffs | FDA UDI | Class II | Active |
| Ultracheck | UltraCheck BP Cuffs | FDA UDI | Class II | Active |
| Softcheck | SoftCheck BP Cuffs | FDA UDI | Class II | Active |
| Statcorp Medical | STATCORP | FDA UDI | Class I | Unknown |
| Statcorp Medical | STATCORP | FDA UDI | Class II | Unknown |
| Softcheck | SoftCheck BP Cuffs | FDA UDI | Class II | Active |
| Ultracheck | UltraCheck BP Cuffs | FDA UDI | Class II | Active |
| Ultracheck | UltraCheck BP Cuffs | FDA UDI | Class II | Active |
| Statcorp Medical | STATCORP | FDA UDI | Class II | Active |
| Ultracheck | UltraCheck BP Cuffs | FDA UDI | Class II | Active |
| Ultracheck | UltraCheck BP Cuffs | FDA UDI | Class II | Active |
| Ultracheck | UltraCheck BP Cuffs | FDA UDI | Class II | Active |
| Unifuser | Unifuser | FDA UDI | Class I | Active |
| Ultracheck | UltraCheck BP Cuffs | FDA UDI | Class II | Active |
| Softcheck | SoftCheck BP Cuffs | FDA UDI | Class II | Active |
| Statcorp Medical | STATCORP | FDA UDI | Class II | Unknown |
| Ultracheck | UltraCheck BP Cuffs | FDA UDI | Class II | Active |
| Softcheck | SoftCheck BP Cuffs | FDA UDI | Class II | Active |
| Statcorp Medical | STATCORP | FDA UDI | Class I | Unknown |
| Statcorp Medical | STATCORP | FDA UDI | Class II | Unknown |
| Softcheck | SoftCheck BP Cuffs | FDA UDI | Class II | Active |
| Ultracheck | UltraCheck BP Cuffs | FDA UDI | Class II | Active |
| Softcheck | SoftCheck BP Cuffs | FDA UDI | Class II | Active |
| Softcheck | SoftCheck BP Cuffs | FDA UDI | Class II | Active |
| Statcorp Medical | STATCORP | FDA UDI | Class II | Unknown |
| SoftCheck | SoftCheck BP Cuffs | FDA UDI | Class II | Active |
| Statcorp Medical | STATCORP | FDA UDI | Class I | Unknown |
| Statcorp Medical | STATCORP | FDA UDI | Class II | Active |
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