TING YU MEDICAL ENTERPRISE CO., LTD.
Tel: 886-4-22757722 Fax: 886-4-22757700E-mail
Ting Yu Medical Enterprise Co., Ltd. have passed ISO13485(DNV) GMP agree.
The materials of Ting Yu water Gel-Patient Lubricant are stable and will contact with patient is skin temporarily.
Ting Yu water Gel-Patient Lubricant according to ISO10993-5/10,the Electrode will comply with Biocompatibility Test including:
1) Cytotoxicity study – ISO 10993-5
2) Skin irritation study – ISO 10993-10
3) Skin sensitization study – ISO 10993-10
Harmonized standard compliance: EN980:2003,EN ISO14971:2007,EN ISO 10993-1:2003
FDA&CE Recognized Consensus standard