Optima XPN 100 - India CDSCO Medical Device Registration

Optima XPN 100 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000313_b9aeddba042df3079a401b0941d33b49_c2495cbb5d609c54e2dd348ef9560cf1. This device is marketed under the brand name Optima XE - 90 - IVD Centrifuge. The license holder is Beckman Coulter India Private Limited, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

Optima XPN 100

UID: IMP/IVD/2022/000313_b9aeddba042df3079a401b0941d33b49_c2495cbb5d609c54e2dd348ef9560cf1

Brand Name

Optima XE - 90 - IVD Centrifuge

License Holder

Beckman Coulter India Private Limited

Device Class

Class A

Approving Authority

CDSCO

Product Information

This Optima XPN centrifuge is intended for use as a general purpose laboratory instrument for the separation of components through the use of relative centrifugal force. Applications may be clinical in nature, including the separation of human samples (Optima XE - 90 - IVD Centrifuge), either alone or after the addition of reagents or other additives; or non-clinical, such as the separation of non-human bodily samples, chemicals, industrial or environmental samples. This centrifuge should be operated by qualified professionals only