Question 1

What types of medical devices does Aditya DispoMed Products Private Limited manufacture?

Accepted Answer

Aditya DispoMed Products Private Limited specializes in single-use surgical tools, specifically manual scalpel blades and complete single-use scalpels. These devices are engineered for one-time clinical use to maintain sterility and minimize contamination risks during surgical procedures.

Question 2

Where is Aditya DispoMed Products Private Limited based?

Accepted Answer

The company is headquartered in the United States. This location ensures compliance with U.S. regulatory standards for medical devices, particularly for single-use surgical instruments.

Question 3

Which regulatory registries list the devices manufactured by Aditya DispoMed Products Private Limited?

Accepted Answer

The company’s devices are included in the FDA’s Unique Device Identification (UDI) system. This registry helps track and identify medical devices like their single-use scalpels and blades, ensuring traceability and regulatory oversight.

Question 4

How are the devices produced by Aditya DispoMed Products Private Limited classified?

Accepted Answer

All devices manufactured by Aditya DispoMed Products Private Limited fall under Class I classification. This classification applies to low-risk devices like single-use scalpels and blades, which are generally exempt from certain regulatory controls but still require compliance with basic safety and performance standards.

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FDA establishments1

What ADITYA DISPOMED PRODUCTS PRIVATE LIMITED makes

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