DHR Holding India Pvt.Ltd.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 50 |
| Class B | Low–moderate risk | 84 |
| Class C | Moderate–high risk | 310 |
| Class D (high risk) | Highest-risk devices | 0 |
CDSCO device licences
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 GermanyThe 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 GermanyThe 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 DenmarkPreheparinized, 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 DenmarkABL8x5 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 DenmarkThe 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 DenmarkABL800 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 DenmarkFor 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 DenmarkAutocheck 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 PolandThis 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 DenmarkFor cleaning the measuring system of the ABL800 Series analyzers
IMP/IVD/2019/000248 · from DenmarkHeparinized plastic capillaries intended for blood sampling
IMP/IVD/2021/000105 · from PolandThe 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 PolandThe 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 DenmarkThe 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 PolandThe 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 PolandFor calibration of pH and electrolyte electrodes in the ABL800 FLEX analyzers.
IMP/IVD/2019/000249 · from DenmarkFor calibration of pH, electrolyte and metabolite electrodes in the ABL800 FLEX analyzers
IMP/IVD/2019/000249 · from DenmarkFor cleaning the measuring system of the ABL837/827/817 FLEX analyzers and for checking high creatinine level.
IMP/IVD/2019/000249 · from DenmarkAutoCheck 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 DenmarkFor cleaning the measuring system of the ABL800 Series analyzers
IMP/IVD/2019/000249 · from DenmarkFor automatic rinse of the measuring system in the ABL800 FLEX analyzers.
IMP/IVD/2019/000249 · from DenmarkSensor Cassette for the ABL90 FLEX PLUS analyzer for measuring the parameters indicated on the sensor cassette.
IMP/IVD/2019/000249 · from DenmarkFor 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 DenmarkFor 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 DenmarkThis 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 DenmarkFor cleaning the measuring system of the ABL837/827/817 FLEX analyzers and for checking high creatinine level.
IMP/IVD/2019/000249 · from DenmarkFor 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 DenmarkFor 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 DenmarkFor calibration of pH, electrolyte and metabolite electrodes in the ABL837/827/817 FLEX analyzers
IMP/IVD/2019/000249 · from DenmarkD744 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 DenmarkD722 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 DenmarkD733 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 DenmarkSensor cassette for the ABL90 FLEX analyzer for measuring the parameters indicated on the sensor cassette.
IMP/IVD/2019/000249 · from DenmarkD7066 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 DenmarkSensor cassette for the ABL90 FLEX analyzer for measuring the parameters indicated on the sensor cassette.
IMP/IVD/2019/000249 · from DenmarkCalibration 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 DenmarkSensor cassette for the ABL90 FLEX analyzer for measuring the parameters indicated on the sensor cassette.
IMP/IVD/2019/000249 · from DenmarkSensor cassette for the ABL90 FLEX analyzer for measuring the parameters indicated on the sensor cassette.
IMP/IVD/2019/000249 · from DenmarkFor 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 DenmarkD799 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 DenmarkD7077 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 DenmarkFor automatic rinse of the measuring system in the ABL837/827/817 FLEX analyzers
IMP/IVD/2019/000249 · from DenmarkD711 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 DenmarkFor 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 DenmarkMembrane 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 DenmarkD755 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 DenmarkD788 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 DenmarkHypochlorite Solution is intended for Protein Removal and Decontamination.
IMP/IVD/2019/000249 · from DenmarkThe 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 ChinaGlobal footprint
Cross-railThe 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.