PEOPLE’S REPUBLIC OF CHINA

REGISTRATION CERTIFICATE FOR MEDICAL DEVICE

CFDA Certified No. 20203100056

Registrant Chengdu OCI Medical Devices Co.,Ltd
No.2401, West Port Avenue, Southwest Airport Economic Development
Registrant Address
Zone, Shuangliu District, Chengdu, Sichuan Province, China.
1st building, 1st, 3rd, 4th floor of the 2nd building, 1-A, 2nd, 3rd,4th of the 3rd
Manufacturer building and 2nd,3rd,4th floor of 6th building, No.2401, West Port Avenue,
Address Southwest Airport Economic Development Zone, Shuangliu District,
Chengdu, Sichuan Province, China
Agent /
Address /
Product Hollow Fiber Membrane Hemodialyzer
OCI-HD15M、OCI-HD16M、OCI-HD17M、OCI-HD18M、OCI-HD19M、
Model OCI-HD20M

This product is composed of hollow fiber membrane, shell, end cap, end
cap and sealing glue. The hollow fiber membrane material is
polyethersulfone, the shell and end cap materials are polypropylene, the
Structure&Component
end cap material is polyethylene, and the sealing glue material is
polyurethane glue. The product is sterilized by irradiation, sterile,
pyrogen-free. The product is for single use.
It is suitable for the hemodialysis treatment of rescue and/or treatment of
Medical indications
patients with acute and chronic renal failure caused by various reasons.
Attachmennt Technical Requirements for Products

Others /

Remarks

Approval Department
State Food and Drug Administration (Seal)
Approval Date 2020.01.15
Valid until 2025.01.14