Merlin Medical W4328 Paediatric
Device Name:
Paediatric
Device Model:
W4328
Manufacturer:

OBL: Williams Medical Supplies Ltd. (Merlin Medical), Craiglas House, The Maerdy Industrial Estate, Rhymney, Tredegar, Gwent NP22 5PY, UNITED KINGDOM.

OEM: Beijing Choice Electronic Technology Co. Ltd. (ChoiceMMed), 4F Jingyang Science and Technology Building, 15 Xijing Road, Shijingshan District, Beijing 100041, CHINA.

Measuring functions:
SpO2, Pulse Rate
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Description:
The Merlin Medical W4328 Paediatric is a fingertip automatic pulse oximeter. Information regarding the accuracy of its oxygen saturation measurement technology does not appear to be available. Oxygen saturation measurements are taken from the finger. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
While the technology used in the Merlin Medical W4328 Paediatric, to measure peripheral oxygen saturation, has been declared, on the manufacturer website, as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Device Family:
ChoiceMMed MD300C5Y, Merlin Medical W4328 PaediatricY
Legend: Y Internal declaration