Pure Global

ROTEM® sigma ROTROL N - India CDSCO Medical Device Registration

ROTEM® sigma ROTROL N is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000088_cc0d8e975c98d45179fff101542edc97_97be74226e8f9ec117fdc2beb97a1899. This device is marketed under the brand name ROTEM®. The license holder is Instrumentation Laboratory India Pvt Ltd, and it is classified as Device Class Class C. 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.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class C
ROTEM® sigma ROTROL N
UID: IMP/IVD/2021/000088_cc0d8e975c98d45179fff101542edc97_97be74226e8f9ec117fdc2beb97a1899

Brand Name

ROTEM®

Device Class

Class C

Approving Authority

CDSCO

Product Information

ROTEM® sigma ROTROL N is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® sigma whole blood hemostasis system. ROTEM® sigma ROTROL N is a level 1 control

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing