Importer / authorised agent · Telangana · India

BIOMERIEUX INDIA PVT. LTD.

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
621
Manufacturing
2
Import
619
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices14
Class BLow–moderate risk469
Class CModerate–high risk131
Class D (high risk)Highest-risk devices7

CDSCO device licences

chromID? VRE Agar · Class BIMPORT · 2026-05-04

Selective chromogenic medium for the detection and differentiation of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE)

IMP/IVD/2020/000873 · from France
chromID® CPS® Elite Agar Translucent medium · Class BIMPORT · 2026-05-04

For Isolation, enumeration and direct and presumptive identification of urinary tract infection organisms

IMP/IVD/2020/000873 · from France
chromID? MRSA SMART Agar · Class BIMPORT · 2026-05-04

Chromogenic medium for the screening of methicillin-resistant Staphylococcus aureus (MRSA)

IMP/IVD/2020/000873 · from France
CLED Agar · Class BIMPORT · 2026-05-04

Isolation of micro-organisms of the urinary tract

IMP/IVD/2020/000873 · from France
Chocolate agar + PolyVitex · Class BIMPORT · 2026-05-04

Isolation of fastidious bacteria.

IMP/IVD/2020/000873 · from France
Columbia agar + 5% sheep blood · Class BIMPORT · 2026-05-04

Isolation of fastidious bacteria and dection of hemolysis.

IMP/IVD/2020/000873 · from France
Mueller Hinton E Agar · Class BIMPORT · 2026-05-04

Study of antimicrobial susceptibility

IMP/IVD/2020/000873 · from France
Mac Conkey Agar · Class BIMPORT · 2026-05-04

Selective isolation of enterobacteria and Escherichia coli

IMP/IVD/2020/000873 · from France
chromID? ESBL agar · Class BIMPORT · 2026-05-04

Selective chromogenic medium for the screening of Extended Spectrum ?-Lactamase-producing enterobacteria (ESBL)

IMP/IVD/2020/000873 · from France
Mueller Hinton 2 agar + 5% sheep blood · Class BIMPORT · 2026-05-04

Susceptibility of pneumococci and other streptococci to antibiotics

IMP/IVD/2020/000873 · from France
Antimicrobial susceptibility test reagent kit · Class BIMPORT · 2026-04-24

The VITEK® 2 Gram-negative Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobi…

IMP/IVD/2019/000035 · from United States
Antimicrobial susceptibility test reagent kit · Class BIMPORT · 2026-04-10

The VITEK® 2 Fungal Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed…

IMP/IVD/2019/000035 · from United States
Antimicrobial susceptibility test reagent kit · Class BIMPORT · 2026-03-20

The VITEK® REVEAL? AST System is an automated system for quantitative and qualitative antimicrobial susceptibility testing (AST) of organisms direct from positive blood culture. The VITEK® REVEAL? AST System does not provide organism identi…

IMP/IVD/2026/000042 · from United States
Antimicrobial susceptibility analyser (VITEK® REVEAL) · Class AIMPORT · 2025-12-30

The VITEK® REVEAL? Instrument is a benchtop incubator that processes up to four AST disposables. Installation and operating details for the VITEK® REVEAL? Instrument are provided in this manual.

IMP/IVD/2019/000035 · from United States
Antimicrobial susceptibility analyser (VITEK® REVEAL SEALER) · Class AIMPORT · 2025-12-30

The Specific Diagnostics VITEK® REVEAL? SEALER provides the heat welding of the VITEK® REVEAL? SENSOR PANEL to the AST PANEL. The VITEK® REVEAL? SEALER is a benchtop device that is used to assemble the AST Sensor and Drug Plates, forming th…

IMP/IVD/2019/000035 · from United States
MTB-RIF/INH (Rifampicin and Isoniazid) resistance detection test reagent kit · Class CMFG · 2025-12-29

MTB-RIF/INH R-GENE Kit is an in-vitro diagnostic assay for simultaneous detection of Rifampicin and Isoniazid resistance determining mutations in mycobacterium tuberculosis positive sputum and culture samples by using Real-Time PCR after nu…

MFG/IVD/2025/000167
MTBc/NTM detection test reagent kit · Class CMFG · 2025-12-29

MTBc/NTM R-GENE kit is an in-vitro diagnostic assay for simultaneous detection and differentiation of Mycobacterium tuberculosis Complex (MTBc) with Nontuberculous mycobacteria (NTM) in sputum samples and cultures, using Real-Time PCR after…

MFG/IVD/2025/000167
ETEST VANCOMYCIN · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
ETEST AZITHROMYCIN · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
ETEST ERTAPENEM · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
ETEST BENZYLPENICILLIN · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
ETEST TEICOPLANIN · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
ETEST MEROPENEM · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
ETEST LINEZOLID · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
ETEST VORICONAZOLE · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antifungal agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
ETEST CIPROFLOXACIN · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
ETEST IMIPENEM · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
ETEST DORIPENEM · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
ETEST AMPHOTERICIN B · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antifungal agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
CEFTAZIDIME/AVIBACTAM CZA · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.

IMP/IVD/2019/000303 · from France
ETEST CASPOFUNGIN · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antifungal agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
ETEST DAPTOMYCIN · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
ETEST CHLORAMPHENICOL · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
ETEST POLYMYXIN B · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
ETEST COLISTIN · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
ETEST MOXIFLOXACIN · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
ETEST FLUCONAZOLE · Class BIMPORT · 2025-12-16

Etest is a manual quantitative technique for determining the MIC of antifungal agents against microorganisms and/or for detection of resistance mechanisms

IMP/IVD/2019/000303 · from France
Etest Benzylpenicillin · Class BIMPORT · 2025-12-01

Etest is a manual quantitative technique for the determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antimicrobial agent…

IMP/IVD/2019/000303 · from France
Etest AZTREONAM · Class BIMPORT · 2025-12-01

Etest is a manual quantitative technique for the determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antimicrobial agent…

IMP/IVD/2019/000303 · from France
ETEST Flucytosine · Class BIMPORT · 2025-10-03

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.

IMP/IVD/2019/000303 · from France
ETEST Erythromycin · Class BIMPORT · 2025-10-03

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.

IMP/IVD/2019/000303 · from France
ETEST Fluconazole · Class BIMPORT · 2025-10-03

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.

IMP/IVD/2019/000303 · from France
ETEST Cefixime · Class BIMPORT · 2025-10-03

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.

IMP/IVD/2019/000303 · from France
ETEST Clarithromycin · Class BIMPORT · 2025-10-03

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.

IMP/IVD/2019/000303 · from France
VITEK MS PRIME Mass Spectrometry Analyser · Class AIMPORT · 2025-10-03

VITEK® MS PRIME is a mass spectrometry system using matrix-assisted laser desorption/ ionization time of flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens. The VITEK® MS PRIME sys…

IMP/IVD/2025/000128 · from United States
ETEST Amoxicillin/Clavulanic Acid · Class BIMPORT · 2025-10-03

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.

IMP/IVD/2019/000303 · from France
ETEST Daptomycin · Class BIMPORT · 2025-10-03

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.

IMP/IVD/2019/000303 · from France
ETEST Azithromycin · Class BIMPORT · 2025-10-03

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.

IMP/IVD/2019/000303 · from France
ETEST Spectinomycin · Class BIMPORT · 2025-10-03

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.

IMP/IVD/2019/000303 · from France
ETEST Trimethoprim Sulfamethoxazole · Class BIMPORT · 2025-10-03

Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.

IMP/IVD/2019/000303 · from France

Global footprint

Cross-rail

The same manufacturer across regulators — 0 FDA clearances, 0 flagged adverse-event signals.

No FDA clearances linked — India-domestic footprint.

Sources: CDSCO (Central Drugs Standard Control Organisation) device licences · openFDA 510(k)/PMA · openFDA MAUDE · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert sign-off in progress.

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