Automatic Endoscope Reprocessor - India CDSCO Medical Device Registration

Automatic Endoscope Reprocessor is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001149_49524449a8ebc0999c84ccf8745c9c25_c72fb97341dcf8cfa96fdd6dfd77bdcc. This device is marketed under the brand name Sterrad. The license holder is Advanced Sterilization Products India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Automatic Endoscope Reprocessor

UID: IMP/MD/2023/001149_49524449a8ebc0999c84ccf8745c9c25_c72fb97341dcf8cfa96fdd6dfd77bdcc

Brand Name

Sterrad

License Holder

Advanced Sterilization Products India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

AEROFLEX Automatic Endoscope Reprocessor (Sterrad) with AUTOSURE™ MRC Monitor is indicated for use with high-level disinfectant ASP AERO OPA™ ortho-Phthalaldehyde Solution to achieve high-level disinfection of semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the AER.