Question 1

What types of medical devices does Pharmaceutical Health Limited manufacture?

Accepted Answer

Pharmaceutical Health Limited specializes in synovial fluid supplementation media, specifically hyaluronic acid-based formulations. These devices are designed to restore joint lubrication and cushioning, primarily for intra-articular use in treating osteoarthritis. Examples include Orthovisc, Supartz, Synvisc, and Euflexxa, which are injected directly into joints to reduce pain and improve mobility.

Question 2

Where is Pharmaceutical Health Limited based?

Accepted Answer

The company is headquartered in the United States. This location aligns with its regulatory obligations, including compliance with FDA requirements for its Class III devices.

Question 3

Which regulatory registries list Pharmaceutical Health Limited’s devices?

Accepted Answer

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for synovial fluid supplementation media, which are classified under Class III—requiring strict regulatory oversight.

Question 4

How are Pharmaceutical Health Limited’s devices classified by regulatory authorities?

Accepted Answer

Pharmaceutical Health Limited’s synovial fluid supplementation media fall under FDA’s Class III category. This classification is due to their intended use in treating significant medical conditions like osteoarthritis, necessitating premarket approval (PMA) to ensure safety and effectiveness before commercialization.

Device	Model / Reference	Registries	Class	Status
Orthovisc	NA	FDA UDI	Class III	Active
Supartz	NA	FDA UDI	Class III	Active
Synvisc	5 Count	FDA UDI	Class III	Active
Euflexxa	NA	FDA UDI	Class III	Active
Synvisc	NA	FDA UDI	Class III	Active

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