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Fully Automated Clinical Chemistry Analyzer - India CDSCO Medical Device Registration

Fully Automated Clinical Chemistry Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000114_c2306a1f799ce8c8daa15a0aac630bfc_52e80c2d737324aa5b66877829b25eca. This device is marketed under the brand name Erba. The license holder is Transasia Bio-Medicals Ltd, and it is classified as Device Class Class A. The approving authority is Greater Mumbai Division.

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 A
Fully Automated Clinical Chemistry Analyzer
UID: MFG/IVD/2022/000114_c2306a1f799ce8c8daa15a0aac630bfc_52e80c2d737324aa5b66877829b25eca

Brand Name

Erba

Device Class

Class A

Approving Authority

Greater Mumbai Division

Product Information

Automatic analyzer with additional ISE module intended for in vitro photometric quantification of clinical chemistry parameters and ion-selective quantification of specific electrolytes (Erba) in serum, plasma and urine with capacity 400 tests per hour. The results for tested clinical chemistry parameters can be used for screening, monitoring, and diagnosis. The function is specifically dependent on each parameter and is described in IFU of every reagent kit provided by ERBA. For professional use in clinical laboratory only

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