6053950CE01

EC CERTIFICATE
Full Quality Assurance System
Directive 93/42/EEC on Medical devices, Annex II excluding (4)
ManufacturerWuxi Apex Medical Co., Ltd.
209 Bld., No.35 South Changjiang Road, Xinwu District
214028 Wuxi, Jiangsu
China
For the product category(ies)
Injection, infusion and channelling devices for continuous or intermittent administration of medication via subcutaneous route
This certificate covers the following product(s):
- Infusion Pumps model HK101
- Insulin Pumps model TruCare I
- Insulin Pumps model TruCare II
- Insulin Pumps model TruCare III
- Sterile Ambulant Drug Reservoirs model Fast Set-I
- Sterile Ambulant Drug Reservoirs model Easy Set-I
- Sterilized Infusion Sets for single use
Status:Valid