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Sign in to claim this brandMeril Life Sciences Private Limited
US
Last updated May 26, 2026
What Meril Life Sciences Private Limited makes
Meril Life Sciences Private Limited manufactures basic coronary angioplasty balloon catheters designed for percutaneous transluminal coronary angioplasty (PTCA). These devices are intended for dilating narrowed coronary arteries to improve blood flow in patients with coronary artery disease.
The company’s portfolio consists of Class II devices, which are regulated under the FDA’s 510(k) premarket notification process and listed in the FDA’s Unique Device Identification (UDI) system. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Meril Life Sciences Private Limited primarily manufacture?
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.
Where is Meril Life Sciences Private Limited based?
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.
Which regulatory registries or databases list Meril Life Sciences Private Limited’s devices?
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.
How are Meril Life Sciences Private Limited’s devices classified under FDA regulations?
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.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- merillife.com
- —
- —
- [email protected]
- Phone
- +1 (609) 951 2287
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 650328680
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