Metene TD-4116

Device Model:

TD-4116

Manufacturer:

OBL: Shen Zhen Shi Ling Ku Dian Zi Shang Wu You Xian Gong Si Ltd. (or Shen Zhen Shi Tong Yuan Dian Zi Shang Wu Co. Ltd.) (Metene), Qinghu Baifuhui Industrial Park, D-402 Jianshe Rd, (or 31C, 4th Apartment, 12th Bld, Meilong Town, Minzhi Street,) Longhua Shenzhen, Guangdong 518000, CHINA.

Measuring functions:

Blood glucose

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Finger

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The Metene TD-4116 is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.

Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Metene TD-4116 to measure blood glucose.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	Not recommended	This device has not been clinically validated.