CDSCO UID IMP/MD/2021/000008_0b159e18aa87267d6f1f59577e659cdb_b04548162a6533c4823c8592f5725906

Biological Indicator

3M India Limited·Device Class Class B·India CDSCO·Brand: Reinforced
Registration details
UID
IMP/MD/2021/000008_0b159e18aa87267d6f1f59577e659cdb_b04548162a6533c4823c8592f5725906
Device class
Class B
Brand name
Reinforced
License holder
3M India Limited
Approving authority
CDSCO
Product information
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H or 490 Auto-reader having software version 4 .0 .0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: STERRAD 100S® Sterilization System, STERRAD NX® Sterilization System (Reinforced), STERRAD 100NX® Sterilization System (Reinforced), STERRAD NX® with ALLClear® Technology Sterilization System (Reinforced), STERRAD 100NX® with ALLClear® Technology Sterilization System (Reinforced), V-PRO® 1 Low Temperature Sterilization System (Reinforced), V-PRO® 1 Plus Low Temperature Sterilization System (Reinforced), V-PRO® maX Low Temperature Sterilization System (Reinforced), V-PRO® 60 Low Temperature Sterilization System (Reinforced), V-PRO® maX 2 Low Temperature Sterilization System (Reinforced) and V-PRO® s2 Low Temperature Sterilization System (Reinforced)
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About this record

Biological Indicator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000008_0b159e18aa87267d6f1f59577e659cdb_b04548162a6533c4823c8592f5725906. This device is marketed under the brand name Reinforced. The license holder is 3M India Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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