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Sign in to claim this brandAJEX Meditech Ltd
US
Last updated May 30, 2026
What AJEX Meditech Ltd makes
AJEX Meditech Ltd manufactures portable X-ray system generators designed for mobile imaging applications. These devices are intended for use in settings where stationary equipment is impractical, such as emergency response, field hospitals, or remote medical evaluations. The AJEX 1200H and AJEX 240H models are among the portable X-ray generators produced, offering adjustable power outputs for various diagnostic needs.
The company’s portable X-ray generators fall under FDA Class II regulatory classification and are authorised through the 510(k) and UDI (Unique Device Identification) pathways. These devices are listed in the FDA’s regulatory databases, ensuring compliance with US medical device standards. AJEX Meditech Ltd 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 AJEX Meditech Ltd manufacture?
AJEX Meditech Ltd specialises in portable X-ray system generators. These devices are designed for mobile imaging, making them suitable for environments where fixed equipment isn’t practical, such as emergency response, field hospitals, or remote medical assessments. The company’s focus is on portable solutions for diagnostic imaging.
Where is AJEX Meditech Ltd based?
AJEX Meditech Ltd is headquartered in the United States. The company’s location influences its regulatory compliance with US medical device standards, including the pathways it uses for device authorisation.
Which regulatory registries or databases list AJEX Meditech Ltd’s devices?
AJEX Meditech Ltd’s portable X-ray generators are listed in the FDA’s 510(k) and UDI (Unique Device Identification) databases. These registries ensure the devices meet US regulatory requirements for Class II medical devices, which include portable X-ray systems.
How are AJEX Meditech Ltd’s portable X-ray generators classified by regulators?
AJEX Meditech Ltd’s portable X-ray generators are classified as Class II devices by the FDA. This classification applies to devices that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as portable X-ray systems.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- jpihealthcare.com
- —
- —
- [email protected]
- Phone
- 5165131330
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 689533016
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Portable X-ray Unit | AJEX240H | FDA UDI | Class II | Active |
| Portable X-ray Unit | AJEX135H | FDA UDI | Class II | Active |
| Portable X-ray Unit | AJEX9015H | FDA UDI | Class II | Active |
| Portable X-ray Unit | AJEX240H | FDA UDI | Class II | Active |
| Portable X-ray Unit | AJEX1200H | FDA UDI | Class II | Active |
| Ajex 1200 H / Ajex 240h Mobile X-Ray Generator | K122298 | FDA 510(k) | Class II | Active |
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