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Copy of Request for Quotation 20241217

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nishtha
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4 views

Copy of Request for Quotation 20241217

Uploaded by

nishtha
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Quoting Target Quote

# Quotation Description Refference 1 Refference 2 Quote price(B L) Annexure


entity price
Market information, share of competing
companies and products, target
hospitals/cases, market trends, price
1 Indian Market Research / IABP market Quoted by BLL Over USD35,000 Over USD35,000 Refer Annexure 1
information, sales channel information,
synergy with existing BLL channels,
Research period: Jan-Mar 2025
Ref: IEC 60601-1-2:2014
*Electrical Safety test for Mera IABP
Medical electrical equipment -
BP3 and Corart A2 P2 balloon, as per Ref: IEC60601-1:2020 Ed3.2
Part 1-2: General requirements for
Electrical safety test and EMC test for IEC60601-1:2020 Ed3.2 Medical electrical equipment - Part 1:
2 Quoted by Test Lab. basic safety and essential Over USD20,000 Over USD20,000 Refer Annexure 2
Mera IABP BP3 and Corart A2 P2 balloon *EMC test for Mera IABP BP3 and General requirements for basic safety
performance - Collateral Standard:
Corart A2 P2 balloon, as per IEC 60601- and essential performance
Electromagnetic disturbances -
1-2:2014
Requirements and tests
Biocompatibility test for IABP balloon
Biocompatibnility test for Mera IABP Ref: ISO 10993-1:2018
3 Quoted by Test Lab. catheter Mera Corart A2 and P2 as per Over USD25,000 Over USD25,000 Refer Annexure 3
Catheter Corart A2 and P2 Biological evaluation of medical devices
ISO10993-1:2018
Biomechanical safety test for Mera IABP Biomechanical safety test for Mera IABP
4 Quoted by BLL Over USD25,000 Over USD25,000 Refer Annexure 4
BP3 and Corart A2 P2 balloon BP3 and Corart A2 P2 balloon
Sterility effectiveness test for Mera IABP
Sterility effectiveness test for Mera IABP
5 Quoted by Test Lab. Catheter Corart A2 and P2, for evaluating Over USD10,000 Over USD10,000 Refer Annexure 5
Catheter Corart A2 and P2
sterility assurance level (SAL)
Toxixity test for Mera IABP Catheter Toxixity test for Mera IABP Catheter
6 Quoted by Test Lab. Over USD15,000 Over USD15,000 Refer Annexure 6
Corart A2 and P2 Corart A2 and P2
Indian regulatory submission fee for Mera Quoted by Inian Submission fee for Mera IABP BP3 and
7 Over 'USD4,150 Over 'USD4,150 Refer Annexure 7
IABP BP3 and Corart A2 P2 balloon authority Corart A2 P2 balloon

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