Question 1

What types of medical devices does Medisafe UK Limited manufacture?

Accepted Answer

Medisafe UK Limited specializes in devices that support the cleaning, disinfection, and sterilization of medical instruments. Their portfolio includes ultrasonic-cleaning water baths for removing debris from instruments, sterilizer/disinfector racks designed to hold instruments during processing, and medical device cleaning agents. Additionally, they produce surgical instrument washers/disinfectors that use either chemical or thermal methods to ensure instruments are thoroughly cleaned and disinfected.

Question 2

Where is Medisafe UK Limited based, and what does that mean for their regulatory compliance?

Accepted Answer

Medisafe UK Limited is based in the United States, which means their devices are subject to FDA regulations. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, indicating they are registered with the FDA. However, regulatory compliance and authorization are determined on a per-device basis, not the company itself.

Question 3

How are Medisafe UK Limited’s devices classified under FDA regulations?

Accepted Answer

Medisafe UK Limited’s devices fall under two classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require less regulatory scrutiny, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and requirements for each device.

Question 4

Which regulatory registries list Medisafe UK Limited’s devices?

Accepted Answer

Medisafe UK Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for healthcare providers and regulators. Listing in this database is a requirement for devices marketed in the United States.

Question 5

What is the significance of Medisafe UK Limited’s device classifications (Class I and Class II)?

Accepted Answer

The FDA’s classification system helps determine the regulatory controls applied to a medical device. Class I devices, like some cleaning or holding racks, typically require general controls such as good manufacturing practices. Class II devices, such as certain surgical instrument washers/disinfectors, may require additional performance standards or post-market surveillance due to their higher risk. This classification ensures appropriate oversight based on the device’s potential impact on patient safety.

Device	Model / Reference	Registries	Class	Status
InnoWave	IWULTRA	FDA UDI	Class I	Active
InnoWave	IW1038	FDA UDI	Class II	Unknown
InnoWave	IWULTRAPL	FDA UDI	Class I	Active
InnoWave	Unity	FDA UDI	Class I	Active
Distal Tip Soaker	Distal Duck	FDA UDI	Class I	Active
InnoWave	IW1010	FDA UDI	Class II	Active
Duck Bag	Duck Bag	FDA UDI	Class I	Active
InnoWave	Eco	FDA UDI	Class I	Active
Niagara	MP21832	FDA UDI	Class II	Active
InnoWave	PCF	FDA UDI	Class II	Active
Duck Bag	Duck Bag	FDA UDI	Class I	Active
InnoWave	Unity	FDA UDI	Class I	Active
InnoWave	Unity	FDA UDI	Class I	Active
InnoWave	Pro	FDA UDI	Class II	Active
Niagara	MP21854	FDA UDI	Class I	Active
Niagara	MP21907	FDA UDI	Class II	Active
InnoWave	IW1037	FDA UDI	Class II	Active
InnoWave	Eco	FDA UDI	Class I	Active
Niagara	MP22036	FDA UDI	Class II	Active
Niagara	MP22062	FDA UDI	Class II	Active
Distal Duck	Distal Duck	FDA UDI	Class I	Active
Duck Bag	Duck Bag	FDA UDI	Class I	Active
Niagara	MP21906	FDA UDI	Class II	Active
Niagara	MP21852	FDA UDI	Class II	Unknown

MEDISAFE UK LIMITED

What MEDISAFE UK LIMITED makes

Frequently asked questions

Information

Catalogue (24)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities