Question 1

What types of medical devices does Cook BioDevice manufacture?

Accepted Answer

Cook BioDevice specializes in the ProFusion Therapeutic Infusion Needle, a device designed for administering therapeutic infusions. These needles are used in medical settings to deliver fluids, medications, or treatments precisely and controllably into the vascular system or other targeted areas. The focus is on infusion-related applications.

Question 2

Where is Cook BioDevice based?

Accepted Answer

Cook BioDevice is headquartered in the United States. The company’s location influences its regulatory compliance processes, particularly for devices intended for global markets, including those subject to EU regulations.

Question 3

Which regulatory registries list Cook BioDevice’s devices?

Accepted Answer

The ProFusion Therapeutic Infusion Needle is listed in the EUDAMED database, which is the European Union’s medical device registry. Listing in EUDAMED is required for devices placed on the EU market, ensuring transparency and traceability for regulatory oversight.

Question 4

How are Cook BioDevice’s devices classified under EU regulations?

Accepted Answer

The ProFusion Therapeutic Infusion Needle falls under Class IIa classification in the EU. This classification is assigned based on risk assessment criteria—Class IIa devices pose a moderate risk and require additional scrutiny, such as conformity assessment procedures, to ensure safety and performance before market placement.

Device	Model / Reference	Registries	Class	Status
ProFusion Therapeutic Infusion Needle	G47571	EUDAMEDFDA UDI	Class IIa	Active
ProFusion Therapeutic Infusion Needle	G47577	EUDAMEDFDA UDI	Class IIa	Active
ProFusion Therapeutic Infusion Needle	G47574	EUDAMEDFDA UDI	Class IIa	Active
ProFusion Therapeutic Infusion Needle	G47572	EUDAMEDFDA UDI	Class IIa	Active
ProFusion Therapeutic Infusion Needle	G47575	EUDAMEDFDA UDI	Class IIa	Active
ProFusion Therapeutic Infusion Needle	G47570	EUDAMEDFDA UDI	Class IIa	Active
ProFusion Therapeutic Infusion Needle	G47580	EUDAMEDFDA UDI	Class IIa	Active
ProFusion Therapeutic Infusion Needle	G47578	EUDAMEDFDA UDI	Class IIa	Active
ProFusion Therapeutic Infusion Needle	G47579	EUDAMEDFDA UDI	Class IIa	Active
ProFusion Therapeutic Infusion Needle	G58475	EUDAMEDFDA UDI	Class IIa	Active
ProFusion Therapeutic Infusion Needle	G47576	EUDAMEDFDA UDI	Class IIa	Active
ProFusion Therapeutic Infusion Needle	G47573	EUDAMEDFDA UDI	Class IIa	Active
ProFusion Therapeutic Infusion Needle	G58474	EUDAMEDFDA UDI	Class IIa	Active

Cook BioDevice

What Cook BioDevice makes

Frequently asked questions

Information

Catalogue (13)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities