E-tender for Rate Contract for Supply of Lifesaving Permanent Implant Product (Item), for Lifesaving Cardiac Operations and Cardiac Procedures (Adult, Paediatric & Neonatal) i.e. Implantable Closure Devices and Delivery Systems for U N Mehta Institute of Cardiology and Research Centre (Affiliated to B. J. Medical College & NABH Accredited) Ahmedabad, Gujarat, India

Technical Compliance Sheet of E - Tender for Rate Contract for Supply of Implantable Closure Devices & Delivery Systems, E - Tender ID # 313362

SN Product (Item) Name Product (Item) Description Required Size Mandatory Product (item) Certification Required for Product (item) Qualification Unit Brand Name Manufacturing Company Reference No. Quoted Size Compliance to the Tender Specification (Yes/No) Deviation, If any

1 ASD Device - All Sizes USFDA approved 1

2 ASD Device - All Sizes CE approved 1

3 ASD Device - All Sizes DCGI approved 1

4 VSD Mid Muscular Device Waist Length 7mm All Sizes USFDA approved 1

5 VSD Mid Muscular Device Waist Length 7mm All Sizes CE approved 1

6 VSD Mid Muscular Device Waist Length 7mm All Sizes DCGI approved 1

7 VSD Peri Membrane Device - All Sizes USFDA approved 1

8 VSD Peri Membrane Device - All Sizes CE approved 1

9 VSD Peri Membrane Device - All Sizes DCGI approved 1

10 Post MI VSD Device Waist Length 10mm All Sizes USFDA approved 1

11 Post MI VSD Device Waist Length 10mm All Sizes CE approved 1

12 Post MI VSD Device Waist Length 10mm All Sizes DCGI approved 1

13 Single disc PDA Device - All Sizes USFDA approved 1

14 Single disc PDA Device - All Sizes CE approved 1

15 Single disc PDA Device - All Sizes DCGI approved 1

16 Double Disc PDA occluder Device - All Sizes USFDA approved 1

17 Double Disc PDA occluder Device - All Sizes CE approved 1

18 Double Disc PDA occluder Device - All Sizes DCGI approved 1

19 Double Disc PDA occluder Device for Preterm - All Sizes USFDA approved 1

20 Double Disc PDA occluder Device for Preterm - All Sizes CE approved 1

21 Double Disc PDA occluder Device for Preterm - All Sizes DCGI approved 1

22 Vascular Plug - Type I Single lobe for short landing zone All Sizes USFDA approved 1

23 Vascular Plug - Type I Single lobe for short landing zone All Sizes CE approved 1

24 Vascular Plug - Type I Single lobe for short landing zone All Sizes DCGI approved 1

25 Vascular Plug - Type II Three lobes for variable landing zone All Sizes USFDA approved 1

26 Vascular Plug - Type II Three lobes for variable landing zone All Sizes CE approved 1

27 Vascular Plug - Type II Three lobes for variable landing zone All Sizes DCGI approved 1

28 Vascular Plug - Type III For Percutaneous Paravalvular leak closure All Sizes USFDA approved 1

29 Vascular Plug - Type III For Percutaneous Paravalvular leak closure All Sizes CE approved 1

30 Vascular Plug - Type III For Percutaneous Paravalvular leak closure All Sizes DCGI approved 1

31 Vascular Plug - Type IV Two lobes for low profile embolization All Sizes USFDA approved 1

32 Vascular Plug - Type IV Two lobes for low profile embolization All Sizes CE approved 1

33 Vascular Plug - Type IV Two lobes for low profile embolization All Sizes DCGI approved 1

34 Patent foramen ovale (P.F.O.) Device - All Sizes USFDA approved 1

35 Patent foramen ovale (P.F.O.) Device - All Sizes CE approved 1

36 Patent foramen ovale (P.F.O.) Device - All Sizes DCGI approved 1

37 Left Atrial Appendage (LAA) Occluder Disc and Lobe mechanism connected with waist All Sizes USFDA approved 1

38 Left Atrial Appendage (LAA) Occluder Disc and Lobe mechanism connected with waist All Sizes CE approved 1

39 Left Atrial Appendage (LAA) Occluder Disc and Lobe mechanism connected with waist All Sizes DCGI approved 1

40 Left Atrial Appendage (LAA) Occluder Disc and Lobe mechanism connected with Waist Pre loaded device All Sizes USFDA approved 1

41 Left Atrial Appendage (LAA) Occluder Disc and Lobe mechanism connected with Waist Pre loaded device All Sizes CE approved 1

42 Left Atrial Appendage (LAA) Occluder Disc and Lobe mechanism connected with Waist Pre loaded device All Sizes DCGI approved 1

43 Left Atrial Appendage Closure (LAAC) Device With Nitinol frame with PET membrane All Sizes USFDA approved 1

44 Left Atrial Appendage Closure (LAAC) Device With Nitinol frame with PET membrane All Sizes CE approved 1

45 Left Atrial Appendage Closure (LAAC) Device With Nitinol frame with PET membrane All Sizes DCGI approved 1

46 Multiple Fenestrated Septal Occluder - All Sizes USFDA approved 1

47 Multiple Fenestrated Septal Occluder - All Sizes CE approved 1

48 Multiple Fenestrated Septal Occluder - All Sizes DCGI approved 1

49 ASD Delivery System - All Sizes USFDA approved 1

50 ASD Delivery System - All Sizes CE approved 1

51 ASD Delivery System - All Sizes DCGI approved 1

52 ASD Delivery System with Ultra flexible tip cable - All Sizes USFDA approved 1

53 ASD Delivery System with Ultra flexible tip cable - All Sizes CE approved 1

54 ASD Delivery System with Ultra flexible tip cable - All Sizes DCGI approved 1

55 VSD Delivery System - All Sizes USFDA approved 1

56 VSD Delivery System - All Sizes CE approved 1

57 VSD Delivery System - All Sizes DCGI approved 1

58 PDA Delivery System - All Sizes USFDA approved 1

59 PDA Delivery System - All Sizes CE approved 1

60 PDA Delivery System - All Sizes DCGI approved 1

61 ASD Sizing Balloon - All Sizes USFDA approved 1

62 ASD Sizing Balloon - All Sizes CE approved 1

63 ASD Sizing Balloon - All Sizes DCGI approved 1

64 Patent foramen ovale (P.F.O.) Device Pre Attached on Flexible Tip Cable - All Sizes USFDA approved 1

65 Patent foramen ovale (P.F.O.) Device Pre Attached on Flexible Tip Cable - All Sizes CE approved 1

66 Patent foramen ovale (P.F.O.) Device Pre Attached on Flexible Tip Cable - All Sizes DCGI approved 1