Question 1

What types of medical devices does Meril Life Sciences Private Limited primarily manufacture?

Accepted Answer

Meril Life Sciences Private Limited specializes in coronary angioplasty balloon catheters, specifically basic models designed for percutaneous transluminal coronary angioplasty (PTCA). These devices are intended to dilate narrowed coronary arteries, helping restore blood flow in patients with coronary artery disease. The company’s focus is on this single category of Class II devices.

Question 2

Where is Meril Life Sciences Private Limited based?

Accepted Answer

The company is headquartered in the United States. This location influences its regulatory compliance, particularly with U.S. authorities like the FDA, which governs the classification and authorization process for its devices.

Question 3

Which regulatory registries or databases list Meril Life Sciences Private Limited’s devices?

Accepted Answer

Meril Life Sciences Private Limited’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system. These registries track Class II devices like their coronary angioplasty balloon catheters, ensuring transparency in their regulatory status and compliance.

Question 4

How are Meril Life Sciences Private Limited’s devices classified under FDA regulations?

Accepted Answer

Meril Life Sciences Private Limited’s devices fall under Class II classification, which is the second-highest risk category for medical devices under FDA regulations. This classification requires premarket notification via the 510(k) process, where the manufacturer demonstrates that their device is substantially equivalent to a legally marketed predicate device. Class II devices are considered to have moderate risk and require special controls to ensure safety and effectiveness.

Device	Model / Reference	Registries	Class	Status
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ30041	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ35038	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ35020	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ27514	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ40020	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ25030	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ35025	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ22538	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ20012	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ22509	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ25017	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ35017	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ45020	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ25038	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ30038	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ25041	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ25025	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ35014	FDA UDI	Class II	Active
MozecTM Rx PTCA Balloon Dilatation Catheter	MOZ27530	FDA UDI	Class II	Active
MESIRE - Balloon Sinus Dilatation System	K172737	FDA 510(k)	Class I	Active
Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter	K181023	FDA 510(k)	Class II	Active
Mozec - Rx Ptca Balloon Dilatation Catheter	K131169	FDA 510(k)	Class II	Active
Mozec NC-Rx PTCA Baloon Dilatation Catheter	K160961	FDA 510(k)	Class II	Active
Aspiron(TM) Aspiration Catheter	K190619	FDA 510(k)	Class II	Active

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