GEM

Karnataka Health & Family Welfare Department Mandya Hematology Analyzer Tender 3 Part V2 IS 550 MDR 2017 2025

Bid Publish Date

23-Nov-2025, 1:41 pm

Bid End Date

03-Dec-2025, 2:00 pm

Location

MANDYA , KARNATAKA

Progress

Issue23-Nov-2025, 1:41 pm
AwardPending
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Quantity

1

Bid Type

Two Packet Bid

Categories 4

ANALYZER MEDICAL EQUIPMENT HEMATOLOGY ANALYZERS CLINICAL DIAGNOSTIC ANALYZERS

Tender Overview

The Karnataka Health and Family Welfare Department, Mandya (PIN 571401) seeks a 3 Part Automated Hematology Analyzer (V2) for hematology testing with automated startup/shutdown, multi-channel WBC/RBC/PLT histograms, Hb measurement, and various running modes. Products must support auto-dilution, three histograms, and high-throughput capability. Key requirements include MDR 2017 compliance, MDR test reports for each batch, in-country OEM/service presence, and NABH calibration certificates. The supplier must provide a complete consumables package with 2/3 shelf-life and reagents with at least 1 year expiry, plus installation, training, and maintenance documentation. This procurement emphasizes uninterrupted spare parts availability for 10 years and toll-free OEM support, including on-site installation and operator training. The tender prioritizes equipment with robust data management, external PC integration, and a comprehensive warranty option. This procurement is location-specific for Mandya, Karnataka, and targets vendors capable of complying with local regulatory and service requirements while delivering within installation and acceptance timelines.

Technical Specifications & Requirements

  • Category: General product information for hematology analyzer; must include automatic startup/shutdown, multiple analysis modes, and Hb measurement.
  • Throughput: specify samples per hour; multi-channel analysis with WBC/RBC/PLT histograms (3 histograms).
  • Data Management: inbuilt/external PC, RAM, processor, USB ports, data transmission to host, and SQL-like database for results/graphics; output printer and display specs.
  • Consumables & Calibration: auto-calibration, calibration materials, calibration certificates per NABH; reagents with minimum 1-year expiry; two sets of tubings; micro capillary adapters; spill/waste alerts; auto dilution option.
  • Power & Environment: power supply type, UPS rating in KVA, backup minutes; operating temperature/humidity; installation and on-site training.
  • Certifications: MDR 2017 compliance, valid drug license, electrical safety standards, manufacturing unit certification; test reports for each batch; supplier must provide all certificates at bid submission or with delivery.
  • Warranty & Support: comprehensive warranty option available; spare part availability for 10 years; toll-free technical support; OEM service presence in India; breakdown response time.

Terms, Conditions & Eligibility

  • Option Clause: quantity may increase/decrease by up to 25% during contract.
  • Delivery: extended delivery timelines justified by option clause; ensure minimum 30 days for added quantity beyond original schedule.
  • Documentation: submit GST, PAN, experience certificates, financial statements, EMD/Security, OEM authorizations, calibration/test reports; maintain MDR compliance.
  • Warranty: optional comprehensive warranty; standard warranty as per catalogue if not opted; broken down by component and service level.
  • Service: direct OEM service center in India; 10-year spare parts availability; installation, demonstration, and operator training included; calibration certificates per NABH; on-site maintenance documentation provided.

Key Specifications

  • Hematology analyzer supporting automated startup/shutdown and multiple analysis modes

  • Three histograms for WBC, RBC, and Platelets

  • Hb measurement capability

  • Auto dilution option and maximum/minimum sample volumes per mode

  • Throughput capacity in samples per hour

  • Data management with host connectivity, RAM/processor specs, USB ports, and printer options

  • Inbuilt/external monitor, PC hard disk, and external storage compatibility

  • Power backup with UPS rating and minutes of backup

  • Consumables supply with 2/3 shelf life, two sets of tubings, reagent expiry ≥ 1 year

  • Alerts for reagent levels and waste disposal, micro capillary adapter availability

  • Environmental operating conditions and NABH-calibration documentation

  • OEM service presence in India and 10-year spare parts availability

  • Calibration certificates and NABH documentation

Terms & Conditions

  • EMD/Performance security values not disclosed; submit as per bid terms

  • Delivery timeline adjustable by 25% quantity variation

  • Mandatory MDR 2017 compliance, MDR test reports for batches

  • OEM presence in India required with 10-year spares

  • Optional comprehensive warranty; installation and training included

  • Minimum consumables with 2/3 shelf life and 1-year reagent expiry

Important Clauses

Payment Terms

No explicit payment terms provided; bidders should expect standard govt terms with advance, milestone, or post-delivery payments per contract

Delivery Schedule

Delivery can be extended by option clause; ensure minimum 30 days for additional quantity; delivery commences from original delivery order date

Penalties/Liquidated Damages

Not explicitly stated; suppliers should anticipate LD provisions per standard government procurement and delivery delays

Bidder Eligibility

  • In-country OEM/service center presence in India

  • Experience supplying hematology analyzers or equivalent equipment

  • Compliance with MDR 2017 and NABH calibration requirements

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Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL Product Description 3 Part Automated Hematology Analyzer
PRODUCT INFORMATION Type of system offered Open system, Closed system
PRODUCT INFORMATION Type of Automation Fully Automatic
PRODUCT INFORMATION Automatic Start Up,shut down and sample analysis Yes
PRODUCT INFORMATION Analysis principle Based on principle of counting and sizing
PRODUCT INFORMATION Multi channel analysis for better resolution Yes
PRODUCT INFORMATION Type of cell counting 3 Part WBC Differential
PRODUCT INFORMATION Testing mode selection available CBC Mode
PRODUCT INFORMATION Analysis available WBC, Lymph#, Lymph%, Granulocytes #, Granulocytes%, Mixed #, Mixed%, RBC, HGB, HCT, MCV, PCV, MCH, MCHC, RDW-SD, RDW-CV, PLT, MPV, PDW-SD, PDW-CV, PCT, PLCR, P-LCC
PRODUCT INFORMATION Should have three histograms of WBC, RBC, PLT Yes
PRODUCT INFORMATION Hb measurement Cyanide free Colorimetry
PRODUCT INFORMATION Types of modes of running sample Open vial, Capillary, Pre dilute
PRODUCT INFORMATION Maximum sample aspiration volume needed in any of modes Less than 50 µl
PRODUCT INFORMATION Minimum sample volume required 20 µl or less
PRODUCT INFORMATION Throughput capacity of analyser in (samples/ hour) 50-60
PRODUCT INFORMATION Availability of Auto dilution Yes
PRODUCT INFORMATION Types of reagents 1 Hemolyzing Reagent,1 Diluent,1 Cleansing Solution
PRODUCT INFORMATION Quality assurance system with calibration and controls Yes
PRODUCT INFORMATION Quality control programs Atleast 3
PRODUCT INFORMATION Type of Calibration Both (automatic and manual)
PRODUCT INFORMATION Double bathing mechanism Yes
PRODUCT INFORMATION Automatic electric clog removal Yes
DATA MANAGEMENT AND DISPLAY Type of data management Inbuilt system
DATA MANAGEMENT AND DISPLAY Display LCD, LED Or higher
DATA MANAGEMENT AND DISPLAY Inbuilt monitor size in inches More than 5
DATA MANAGEMENT AND DISPLAY PC Monitor size (When PC provided externally) 17 inches or more, NA (if Inbuilt system)
DATA MANAGEMENT AND DISPLAY PC hard disk 1TB, NA
DATA MANAGEMENT AND DISPLAY RAM capacity of PC System 4 GB, NA (if no PC provided)
DATA MANAGEMENT AND DISPLAY Processor i5 or more, NA
DATA MANAGEMENT AND DISPLAY Type of external storage USB
DATA MANAGEMENT AND DISPLAY Number of USB Port 4
DATA MANAGEMENT AND DISPLAY Data management systems Provide histograms in display and print
DATA MANAGEMENT AND DISPLAY Type of user Interface or data entry All three (touchscreen, handheld barcode reader facility and manual)
DATA MANAGEMENT AND DISPLAY Database capability of storing sets of results and graphics ≥ 50000
DATA MANAGEMENT AND DISPLAY Ability to transmit results to host computer Yes
DATA MANAGEMENT AND DISPLAY Type of printer unit Inbuilt, External
DATA MANAGEMENT AND DISPLAY Printer type Black & White Laser Printer, Thermal Printer
POWER REQUIREMENTS Type of power supply 230-240 VAC,50-60 Hz
POWER REQUIREMENTS Power Backup facility Yes
POWER REQUIREMENTS Type of UPS Online, Offline
POWER REQUIREMENTS Rating of UPS in KVA 0.5
POWER REQUIREMENTS Back up time in minutes 15, 30, 60, 120 Or higher
Accessories, spare parts and consumables Offered equipment unit to be supplied with sufficient consumables (with at least 2/3rd of total shelf life) required for, sufficient to carry out haematological testing of samples 500, 1000
Accessories, spare parts and consumables Two set of all tubings Yes
Accessories, spare parts and consumables Reagent expiry time should be minimum of 1 year Yes
Accessories, spare parts and consumables Alerts for operator for level of reagents and to empty waste when indicated Yes
Accessories, spare parts and consumables Availability of micro capillary adapter Yes
Accessories, spare parts and consumables Operating temperature and humidity Capable of operating continuously in ambient temperature of 15 to 35 deg C and relative humidity of 15 to 85% in ideal circumstances
CERTIFICATION AND REPORTS Compliance to Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATION AND REPORTS Availability of valid drug license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date Yes
CERTIFICATION AND REPORTS Manufacturing unit certification ISO:13485 (Latest)
CERTIFICATION AND REPORTS Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATION AND REPORTS Electrical Safety Standards IEC/EN 60601-1 or equivalent BIS Standard
CERTIFICATION AND REPORTS Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission and/or along with supplies as per buyer requirement Yes
WARRANTY Warranty in years (Option of comprehensive warranty is available through bidding only, which if opted will supersede normal warranty in the catalogue) 2, 3, 5 Or higher
Miscellaneous Parameters User/Technical/Maintenance manuals to be supplied in English in hard and soft copy Yes
Miscellaneous Parameters Details of equipments and procedures required for local calibration and routine maintenance to be supplied and advanced maintenance task documentation also to be furnished Yes
Miscellaneous Parameters List of important spares and accessories, with their part numbers to be supplied to the buyer at the time of supplying the equipment Yes
Miscellaneous Parameters The Principal Manufacturer must have direct Presence/approved service center In India Yes
Miscellaneous Parameters OEM/Reseller shall ensure uninterrupted availability of all spares for 10 years Yes
Miscellaneous Parameters Availability of toll free facility for technical support maintened by OEM or authorized agencies Yes
Miscellaneous Parameters Installation and demonstration of equipment and training to be provided after completing supplies before acceptance Yes
Miscellaneous Parameters Calibration certificates as per NABH requirement Yes
Miscellaneous Parameters Time to attend breakdown calls within 48 hrs

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Historical Data

Required Documents

1

GST registration certificate

2

Permanent Account Number (PAN) card

3

Experience certificates of similar hematology analyzer supply

4

Financial statements (latest audited or statutory)

5

EMD/Security deposit proof

6

Technical bid documents and compliance certificates

7

OEM/Manufacturer authorization/agency appointment

8

Calibrations and MDR test reports for supplied batches

9

Electrical safety certificates and licensing

Frequently Asked Questions

Key insights about KARNATAKA tender market

How to bid for the hematology analyzer tender in Mandya Karnataka 2025

Bidders must submit GST, PAN, experience certificates, financial statements, EMD, OEM authorizations, and MDR/NABH calibration reports. Ensure compliance with MDR 2017, provide OEM service presence in India, and include installation, training, and spare parts plan. Follow the specific delivery and warranty terms stated.

What documents are required for the Mandya hematology analyzer procurement

Required documents include GST registration, PAN, recent financial statements, experience certificates for similar supplies, EMD submission proof, OEM authorization, calibration/test reports per MDR, electrical safety certificates, and NABH calibration documentation; ensure all are current and valid.

What are the technical specifications for the 3 part analyzer in this bid

Key specs include three histograms for WBC/RBC/PLT, Hb measurement, auto-dilution option, multiple running modes, sample throughput per hour, data management with host transmission, and inbuilt/external monitor; must support NABH calibration and MDR compliance.

What is the expected warranty and maintenance terms for this procurement

A comprehensive warranty option is available; if chosen, it supersedes catalogue warranty. Also ensure 10-year spare parts availability, OEM-supported maintenance, and on-site installation/training with calibration certificates per NABH.

What are the delivery terms and option clause for quantity changes

The contract allows +/- 25% quantity variation; delivery periods may extend accordingly. Additional time is calculated as (Increased quantity/Original quantity) × Original delivery period with a minimum of 30 days.

What standards and certifications must the supplier provide

Mandatory MDR 2017 compliance, electrical safety standards, valid drug license for the product, manufacturing unit certification, batch test reports per MDR, and NABH calibration certificates; submit all at bid or with delivery.

How is data management and host transmission handled for the analyzer

The analyzer must support data management with results/graphics storage, host transmission, USB connectivity, printer option, and PC RAM/processor suitable for real-time operation; ensure NABH and MDR compliant software interface.

What is required for in-country OEM service support in India

The principal manufacturer must have direct presence or approved service center in India; provide toll-free technical support, routine maintenance, and timely spare parts supply for 10 years after supply.

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