Importer / authorised agent · Tamil Nadu · India

DHR Holding 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
444
Manufacturing
0
Import
444
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices50
Class BLow–moderate risk84
Class CModerate–high risk310
Class D (high risk)Highest-risk devices0

CDSCO device licences

Automated Coverslipper · Class AIMPORT · 2026-04-01

The Histocore Chromax CV Robotic Coverslipper is a cover slipper for laboratory applications and intended for the preparation of histological tissue samples. This Product is used for glass cover slipping, etc. before pathological analysis.I…

IMP/IVD/2022/000314 · from Germany
Automated Slide Stainer · Class AIMPORT · 2026-04-01

The Histocore Chromax ST automated slide Stainer is an automated Stainer for laboratory applications and intended for the preparation of histological tissue samples. This product is used for Staining of cells, tissue samples, etc. before pa…

IMP/IVD/2022/000314 · from Germany
ABL90 · Class CIMPORT · 2026-03-18

The ABL90 FLEX PLUS analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, creatinine, urea/BUN and oximetry in whole blood. The ABL90 FLEX PLUS analyzer is intended for use by t…

IMP/IVD/2019/000249 · from Denmark
PICO70 · Class AIMPORT · 2026-03-18

Preheparinized, electrolyte balanced, arterial blood sampler product line for collection of arterial samples for Ph, blood gas, oximetry, electrolyte and metabolite analysis.

IMP/IVD/2021/000105 · from Denmark
ABL815,ABL825,ABL835 w/Autocheck · Class CIMPORT · 2026-03-17

ABL8x5 FLEX Analyzer modules: BG, El/Met, Oxi ABL8xx is sold in 10 different parameter variants. The variants are defined by the present measuring modules and the available parameters. The availability of the parameters is controlled by …

IMP/IVD/2019/000249 · from Denmark
ABL90 · Class CIMPORT · 2026-03-17

The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, ph…

IMP/IVD/2019/000249 · from Denmark
ABL8XX · Class CIMPORT · 2026-03-17

ABL800 BASIC Analyzer modules: BG, El/Met, Oxi ABL8xx is sold in 10 different parameter variants. The variants are defined by the present measuring modules and the available parameters. The availability of the parameters is controlled by …

IMP/IVD/2019/000249 · from Denmark
AQT90 · Class CIMPORT · 2026-03-17

For in vitro diagnostic use. The AQT90 FLEX analyzer is an immunoassay instrument based on the quantitative determination of time-resolved flu-orescence to estimate the concen-trations of clinically relevant markers on whole blood and plas…

IMP/IVD/2019/000249 · from Denmark
AutoCheck5+ · Class CIMPORT · 2026-02-17

Autocheck is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. For professional use.

IMP/IVD/2019/000248 · from Poland
AutoCheck6+ · Class CIMPORT · 2026-02-17

This AutoCheck6+ Solution is an assayed quality control system for evaluating the quality and precision of all parameters listed on the insert specifying the control ranges. For professional use.

IMP/IVD/2019/000248 · from Denmark
Cleaning solution with additive, ABL8XX · Class CIMPORT · 2026-02-17

For cleaning the measuring system of the ABL800 Series analyzers

IMP/IVD/2019/000248 · from Denmark
Safe Clinitubes · Class BIMPORT · 2026-02-06

Heparinized plastic capillaries intended for blood sampling

IMP/IVD/2021/000105 · from Poland
ABL80 SP80 CO-OX · Class CIMPORT · 2026-01-01

The solution pack provides the necessary reagents, packaged in sealed foil pouches, for use in the calibration and automatic quality control of the sensors

IMP/IVD/2019/000248 · from Poland
ABL9 Analyzer · Class CIMPORT · 2026-01-01

The ABL9 analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, lactate and hematocrit in whole blood. The ABL9 analyzer system is intended for use by trained technologists, nurses, physicians and therapists…

IMP/IVD/2019/000248 · from Denmark
SP9 Solution Pack · Class CIMPORT · 2026-01-01

The ABL9 is a portable automated analyzer that measures pH, Blood gases, electrolytes, lactate and hematocrit in whole blood. The ABL9 is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use i…

IMP/IVD/2019/000248 · from Poland
ABL80 SP80 · Class CIMPORT · 2026-01-01

The solution pack provides the necessary reagents, packaged in sealed foil pouches, for use in the calibration and automatic quality control of the sensors

IMP/IVD/2019/000248 · from Poland
S1830 Calibration solution 2 · Class CIMPORT · 2025-12-18

For calibration of pH and electrolyte electrodes in the ABL800 FLEX analyzers.

IMP/IVD/2019/000249 · from Denmark
S1820 Calibration solution 1 · Class CIMPORT · 2025-12-18

For calibration of pH, electrolyte and metabolite electrodes in the ABL800 FLEX analyzers

IMP/IVD/2019/000249 · from Denmark
S1837 Calibration solution 2 · Class CIMPORT · 2025-12-18

For cleaning the measuring system of the ABL837/827/817 FLEX analyzers and for checking high creatinine level.

IMP/IVD/2019/000249 · from Denmark
AutoCheck5+ · Class CIMPORT · 2025-12-18

AutoCheck is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. For professional use.

IMP/IVD/2019/000249 · from Denmark
Cleaning solution with additive, ABL8XX · Class CIMPORT · 2025-12-18

For cleaning the measuring system of the ABL800 Series analyzers

IMP/IVD/2019/000249 · from Denmark
S4980 Rinse solution · Class CIMPORT · 2025-12-18

For automatic rinse of the measuring system in the ABL800 FLEX analyzers.

IMP/IVD/2019/000249 · from Denmark
ABL 90 Flex Sensor Cassette (SC90 Ki) · Class CIMPORT · 2025-12-18

Sensor Cassette for the ABL90 FLEX PLUS analyzer for measuring the parameters indicated on the sensor cassette.

IMP/IVD/2019/000249 · from Denmark
ABL 90 Flex Solution Pack (SP90 Ki) · Class CIMPORT · 2025-12-18

For calibration of sensors, quality control, evaluation of accuracy and precision, rinse of measuring system and collection of waste from the ABL90 FLEX PLUS analyzer when configured to feature creatinine and urea/BUN parameters.

IMP/IVD/2019/000249 · from Denmark
ABL90 Flex Solution Pack SP90 · Class CIMPORT · 2025-12-18

For calibration of sensors, quality control, evaluation of accuracy and precision, rinse of measuring system and collection of waste from the ABL90 FLEX and ABL90 FLEX PLUS analyzers.

IMP/IVD/2019/000249 · from Denmark
AutoCheck6+ · Class CIMPORT · 2025-12-18

This AutoCheck6+ solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. For professional use

IMP/IVD/2019/000249 · from Denmark
S8377 Cleaning metabolite II · Class CIMPORT · 2025-12-18

For cleaning the measuring system of the ABL837/827/817 FLEX analyzers and for checking high creatinine level.

IMP/IVD/2019/000249 · from Denmark
QUALICHECK5+ · Class CIMPORT · 2025-12-18

For in vitro diagnostic use. This QUALICHECK+ solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. For professional use.

IMP/IVD/2019/000249 · from Denmark
QUALICHECK4+ · Class CIMPORT · 2025-12-18

For in vitro diagnostic use. This QUALICHECK+ solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. For professional use.

IMP/IVD/2019/000249 · from Denmark
S1827 Calibration solution 1 · Class CIMPORT · 2025-12-18

For calibration of pH, electrolyte and metabolite electrodes in the ABL837/827/817 FLEX analyzers

IMP/IVD/2019/000249 · from Denmark
D744 Membrane box for E744 electrode ? Cl? · Class CIMPORT · 2025-12-09

D744 Membrane Box for Cl- Electrode. 4 premembraned electrode jackets each filled with electrolyte solution. For in vitro diagnostic use only.

IMP/IVD/2019/000249 · from Denmark
D722 Membrane box for E722 electrode ? K+ · Class CIMPORT · 2025-12-09

D722 Membrane Box for K+ Electrode. 4 premembraned electrode jackets each filled with electrolyte solution. For in vitro diagnostic use only.

IMP/IVD/2019/000249 · from Denmark
D733 Membrane box for E733 electrode ? Ca2+ · Class CIMPORT · 2025-12-09

D733 Membrane Box for Ca2+ Electrode. 4 premembraned electrode jackets each filled with electrolyte solution. For in vitro diagnostic use only.

IMP/IVD/2019/000249 · from Denmark
Sensor Cassette Pack (SC90) · Class CIMPORT · 2025-12-09

Sensor cassette for the ABL90 FLEX analyzer for measuring the parameters indicated on the sensor cassette.

IMP/IVD/2019/000249 · from Denmark
D7066 Membrane box for E7066 electrode ? Glu · Class CIMPORT · 2025-12-09

D7066 Membrane Box for Glucose Electrode. 4 premembraned electrode jackets each filled with electrolyte solution. For in vitro diagnostic use only.

IMP/IVD/2019/000249 · from Denmark
Sensor Cassette Pack (SC90) · Class CIMPORT · 2025-12-09

Sensor cassette for the ABL90 FLEX analyzer for measuring the parameters indicated on the sensor cassette.

IMP/IVD/2019/000249 · from Denmark
S7770 ctHb Calibration Solution for ABL700 Series · Class CIMPORT · 2025-12-09

Calibration solution for the oximetry module of the ABL700 Series, ABL800 FLEX, ABL800 BASIC, ABL80 FLEX CO-OX, the ABL90 FLEX and ABL90 FLEX PLUS analyzers. For in vitro diagnostic use.

IMP/IVD/2019/000249 · from Denmark
Sensor Cassette Pack (SC90) · Class CIMPORT · 2025-12-09

Sensor cassette for the ABL90 FLEX analyzer for measuring the parameters indicated on the sensor cassette.

IMP/IVD/2019/000249 · from Denmark
Sensor Cassette Pack (SC90) · Class CIMPORT · 2025-12-09

Sensor cassette for the ABL90 FLEX analyzer for measuring the parameters indicated on the sensor cassette.

IMP/IVD/2019/000249 · from Denmark
QUALICHECK4+ · Class CIMPORT · 2025-12-09

For in vitro diagnostic use. This QUALICHECK+ solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. For professional use.

IMP/IVD/2019/000249 · from Denmark
D799 Membrane box for E799 electrode ? pO2 · Class CIMPORT · 2025-12-09

D799 Membrane Box for pO2 Electrode. 4 premembraned electrode jackets each filled with electrolyte solution. For in vitro diagnostic use only.

IMP/IVD/2019/000249 · from Denmark
D7077 Membrane box for E7077 electrode ? Lac · Class CIMPORT · 2025-12-09

D7077 Membrane Box for Lactate Electrode. 4 premembraned electrode jackets each filled with electrolyte solution. For in vitro diagnostic use only.

IMP/IVD/2019/000249 · from Denmark
S4987 Rinse solution II · Class CIMPORT · 2025-12-09

For automatic rinse of the measuring system in the ABL837/827/817 FLEX analyzers

IMP/IVD/2019/000249 · from Denmark
D711 Membrane box for E1001 electrode ? Ref · Class CIMPORT · 2025-12-09

D711 Membrane Box for Reference Electrode. 4 premembraned electrode jackets each filled with electrolyte solution. For in vitro diagnostic use only.

IMP/IVD/2019/000249 · from Denmark
AQT90 FLEX Cleaning Tube Solution · Class CIMPORT · 2025-12-09

For in vitro diagnostic use. For cleaning the sample-handling part of the liquid-transport system of the AQT90 FLEX analyzer.

IMP/IVD/2019/000249 · from Denmark
ABL800 Flex CREA A + B membrane units · Class CIMPORT · 2025-12-09

Membrane box for Crea A and Crea B electrodes D8088 and D8089 2 Crea A and 2 Crea B premembraned electrode jackets and 4 capsules of electrolyte solutions. For in vitro diagnostic use only.

IMP/IVD/2019/000249 · from Denmark
D755 Membrane box for E755 electrode ? Na+ · Class CIMPORT · 2025-12-09

D755 Membrane Box for Na+ Electrode. 4 premembraned electrode jackets each filled with electrolyte solution. For in vitro diagnostic use only.

IMP/IVD/2019/000249 · from Denmark
D788 Membrane box for E788 electrode ? pCO2 · Class CIMPORT · 2025-12-09

D788 Membrane Box for pCO2 Electrode. 4 premembraned electrode jackets each filled with electrolyte solution. For in vitro diagnostic use only.

IMP/IVD/2019/000249 · from Denmark
S5362 Hypochlorite Solution · Class CIMPORT · 2025-12-09

Hypochlorite Solution is intended for Protein Removal and Decontamination.

IMP/IVD/2019/000249 · from Denmark
Aspirating blood syringe, 80 IU Heparin; PICOA · Class BIMPORT · 2025-10-29

The PICO A is a preheparinized, electrolyte-balanced aspirating sampler for the collection of arterial and venous blood for analysis of pH, blood gases, oximetry, electrolytes, and metabolites. It is intended for use by healthcare professio…

IMP/IVD/2025/000149 · from China

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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