GEM

Health & Family Welfare Department Gujarat Hemoglobin Test Strips Tender Dahej/Daodh 2025 MDR 2017

Posted

18 Oct 2025, 02:57 pm

Deadline

08 Nov 2025, 03:00 pm

EMD

₹49,500

Progress

Issue18 Oct 2025, 02:57 pm
AwardPending
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Quantity

66000

Bid Type

Two Packet Bid

Tender Overview

The Gujarat Health & Family Welfare Department seeks supply of Hemoglobin Test Strips for the Daodh, Gujarat region, with an estimated bid value not disclosed and an Earnest Money Deposit (EMD) of ₹49,500. Bidder must comply with MDR 2017, possess a valid drug license under the Drugs and Cosmetic Act, and provide manufacturing unit certification. The contract accommodates potential quantity fluctuations up to 25% per order, with delivery timelines linked to the original delivery period and extended terms. Advance sample provision is required for buyer approval prior to supply. This procurement emphasizes regulatory compliance, product traceability, and batch-wise test reports, ensuring supply integrity for health services.

Technical Specifications 1 Item

Item #1 Details

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Category Specification Requirement
GENERAL FEATURES Product Description Hemoglobin Test Strip
PRODUCT INFORMATION Parameter Measured Hemoglobin (Hb) Level
PRODUCT INFORMATION Sample Type Whole Blood (Capillary/Venous/Arterial)
PRODUCT INFORMATION Type Reagent Free Hemoglobin Strip
PRODUCT INFORMATION Sample Size ≤50 microliters (µL)
PRODUCT INFORMATION Working Principle Absorbance Photometry
PRODUCT INFORMATION Measurement Range 0 to 23 g/dL or more Or higher
PRODUCT INFORMATION Measurement Time ≤ 60 Seconds
PACKAGING Packaging Type Vial
PACKAGING Packing Insert in English provided with each pack Yes
PACKAGING Storage Conditions 2°C-30°C
CERTIFICATIONS & REPORTS Compliance to Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS & 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
CERTIFICATIONS & REPORTS Manufacturing unit certification ISO:13485 (Latest)
CERTIFICATIONS & REPORTS Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date Yes
SHELF LIFE Shelf life in months from the date of Manufacture 24, 36 Or higher
SHELF LIFE Minimum Shelf life available at the time of delivery to the consignee 3/4th of total shelf life
SHELF LIFE Shelf life after first opening of the pack (months) Minimum 3 months or more
ADVANCE SAMPLE Agree to provide advance sample of the product for buyer's approval before commencement of supply in case of bidding Yes, No

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Required Documents

1

Experience Criteria

2

Past Performance

3

Bidder Turnover

4

Certificate (Requested in ATC)

5

OEM Authorization Certificate

6

Additional Doc 1 (Requested in ATC) *In case any bidder is seeking exemption from Experience / Turnover Criteria

7

the supporting documents to prove his eligibility for exemption must be uploaded for evaluation by the buyer

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