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Biological Indicator - India CDSCO Medical Device Registration

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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class B
Biological Indicator
UID: IMP/MD/2021/000008_0b159e18aa87267d6f1f59577e659cdb_b04548162a6533c4823c8592f5725906

Brand Name

Reinforced

License Holder

3M India Limited

Device Class

Class B

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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