Medical Device Regulation
At Graphnet, we are committed to providing medical devices and accessories that meet the highest standards of quality and regulatory compliance. All our compatible accessories undergo rigorous testing to ensure they align with the regulatory requirements of digital health and medical device safety.
Stringent Compliance for Digital Health Devices
As digital health regulations continue to tighten, it’s crucial that all Graphnet connected devices meet the necessary regulatory certifications. This ensures that every accessory is fully compliant with the latest medical device regulations and directives.
We classify our devices into two main categories:
· Connected Devices: These devices are directly linked to DOCOBOAPP™ and are fully compliant with the relevant medical device regulations.
· Unconnected Devices: These devices are manually operated and require data entry by the patient. They are not subject to the same regulatory certifications as connected devices.
Connected Devices
The following connected accessories are fully approved for use with DOCOBOAPP™. These devices are certified under Directive 93/42/EEC on Medical Devices, Annex V and carry CE certification No. 68052.
When used with DOCOBOAPP™, vital sign measurements are automatically transferred, eliminating the need for manual data entry.
Approved Connected Devices List
· AND
- AND UA-656BLE Bluetooth Blood Pressure Monitor
- AND UC-352BLE Bluetooth Scales
· MARSDEN
- Marsden M-420 Bluetooth Scales
- Marsden M-550 Bluetooth Scales
· NONIN
- Nonin WristOx2 3150 Bluetooth Pulse Oximeter
- Nonin Smart 3240 Bluetooth Pulse Oximeter
· AGAMATRIX
- Wavesense Jazz Glucometer
· MICROLIFE
- Microlife NC150BT Bluetooth Thermometer
Unconnected Devices
In addition to connected devices, we supply medically approved unconnected devices that meet CE certification requirements. These devices require manual data entry by the patient and do not fall under regulatory certification for connected devices.
Approved Manual Entry Devices
· Manual BP Monitors
- A&D UA-767S BP Monitor
- A&D UA-767S-W BP Monitor
- A&D UB-525 Wrist BPM
- A&D UB-543 Wrist BPM
- A&D UA-611 Consumer BP Monitor
· Manual Scales
- Marsden M-550 Class III Scales
- Marsden M-430 Class III Scale
- Salter Max Cap. Scales 9049
- Salter Max Cap. Scales 9075
· Manual SpO2
- Creative PC60B1 Pulse Oximeter
- Nonin 3212 IPOD Standard Oximeter
· Manual Thermometers
- Braun Thermoscan 3 Tympanic Thermometer
- Jumper JPD-FR203 Non-contact IR Thermometer
· Glucose Meters
- GlucoRx Nexus Blood Glucose Meter
Changing List of Unconnected Devices
Graphnet periodically reviews and updates this list to ensure it includes the latest compliant accessories. Devices that are outdated or obsolete may be removed. We recommend checking this page regularly for the most current list.
Additionally, we welcome requests to integrate devices that are not yet listed. Our team is ready to assist with the integration process and guide you through the certification approvals.
Get in Touch
If you have any questions or would like more information about our Virtual Ward Solution, reach out to our team today.
