Controls(e-CHECK L2) - India CDSCO Medical Device Registration

Controls(e-CHECK L2) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000162_fd2969ad24699170d4a6a2db3c1b6ed8_20548be86282de9d5cf010d673736ba8. This device is marketed under the brand name EIGHTCHECK-3WP-H. The license holder is Sysmex India Pvt. Ltd., 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.

Free Database

CDSCO Registered

Class Class B

Controls(e-CHECK L2)

UID: IMP/IVD/2019/000162_fd2969ad24699170d4a6a2db3c1b6ed8_20548be86282de9d5cf010d673736ba8

Brand Name

EIGHTCHECK-3WP-H

License Holder

Sysmex India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

e-CHECK(EIGHTCHECK-3WP-H) is a hematology control material primarily for intralaboratory quality control of automated, semiautomated and manual procedures that measure components of the blood. Additionally, e-CHECK(EIGHTCHECK-3WP-H) can be used in external quality assessment. Do not use e-CHECK(EIGHTCHECK-3WP-H) to calibrate the instrument

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Controls(e-CHECK L2)

Brand: EIGHTCHECK-3WP-H

Sysmex India Pvt. Ltd.

Controls(e-CHECK L2) - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Controls(e-CHECK L2)

Controls(e-CHECK L3)

Calibrator

Calibrator

Calibrator

Controls(e-Check L3)

Controls(e-CHECK L1)

Controls(e-CHECK L1)

Controls

Controls

Sheath Fluid

Cl Electrode

Na Electrode

K Electrode

Diluent

L Solution

REF Solution

Ref Electrode

H Solution

ISE Cleaner