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NORFOLK MEDICAL

US

Last updated May 24, 2026

What NORFOLK MEDICAL makes

Norfolk Medical manufactures implantable vascular access ports, single-use infusion and administration sets, hypodermic needles, and subcutaneous infusion systems. Their products include vascular access ports designed for repeated intravenous access, electric infusion pump administration sets, and vascular catheter introduction kits. The company also produces subcutaneous infusion sets for multi-site delivery of fluids or medications.

These devices are classified as Class II under US regulations and are authorised via FDA pathways, including 510(k) premarket notifications and the Unique Device Identifier (UDI) system. The company’s products are listed in the FDA’s regulatory databases, and 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 Norfolk Medical manufacture?

Norfolk Medical specialises in vascular access and infusion-related devices. Their portfolio includes implantable vascular access ports for repeated intravenous access, single-use electric infusion pump administration sets, hypodermic needles, vascular catheter introduction sets, and subcutaneous infusion systems for multi-site fluid or medication delivery. These products are designed to support long-term or targeted administration of therapies in clinical settings.

Where is Norfolk Medical based, and how does that affect its regulatory standing?

Norfolk Medical is headquartered in the United States. As a US-based manufacturer, its devices are subject to FDA regulations, including premarket pathways like 510(k) notifications and compliance with the Unique Device Identifier (UDI) system. The company’s regulatory framework is governed by US federal laws, ensuring its products meet safety, performance, and labelling requirements before authorisation.

Which regulatory registries or databases list Norfolk Medical’s devices?

Norfolk Medical’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k) premarket notification program and the Unique Device Identifier (UDI) system. These registries track authorised medical devices in the US, including their classification, intended use, and compliance status. The listings reflect the manufacturer’s adherence to FDA requirements for Class II devices.

How are Norfolk Medical’s devices classified under US regulations, and why?

Norfolk Medical’s devices are classified as Class II under the FDA’s regulatory framework. This classification applies to products that generally pose moderate risk and require special controls—such as performance standards, post-market surveillance, or labelling requirements—to ensure safety and effectiveness. Implantable ports, infusion sets, and vascular catheters fall into this category due to their role in direct patient access and administration of therapies.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
—
Phone
+1(847)674-7075
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
013861471

Catalogue (276)

Page 1 of 6
DeviceModel / ReferenceRegistriesClassStatus
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
TidalPort Vascular Access Port TidalPort
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
Clear-View Subcutaneous Infusion Set Clear-View "Sub-Q"
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
Clear-View Multi-site Subcutaneous Infusion Set ClearView™MS
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
Aqua-C Subcutaneous Hydration System Aqua-C
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
TidalPort Vascular Access Port TidalPort
FDA UDI
Class IIActive
Clear-View Subcutaneous Infusion Set Clear-View "Sub-Q"
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
Clear-View Multi-site Subcutaneous Infusion Set ClearView™MS
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
Clear-View MAX "Sub-Q" Infusion Set ClearView™MAX
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
TidalPort Vascular Access Port TidalPort
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
TidalPort Vascular Access Port TidalPort
FDA UDI
Class IIActive
Clear-View MAX "Sub-Q" Infusion Set ClearView™MAX
FDA UDI
Class IIActive
Tidal High-Flow Non-coring Needle Tidal-HF
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
Clear-View Subcutaneous Infusion Set Clear-View "Sub-Q"
FDA UDI
Class IIActive
Standard Introducer Straight Wing Tearaway
FDA UDI
Class IIActive
TidalPort Vascular Access Port TidalPort
FDA UDI
Class IIActive
Clear-View Subcutaneous Infusion Set Clear-View "Sub-Q"
FDA UDI
Class IIActive
Clear-View Subcutaneous Infusion Set Clear-View "Sub-Q"
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
Clear-View Subcutaneous Infusion Set Clear-View "Sub-Q"
FDA UDI
Class IIActive
Clear-View MAX "Sub-Q" Infusion Set ClearView™MAX
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
Tidal High-Flow Non-coring Needle Tidal-HF
FDA UDI
Class IIActive
NorPort Vascular Access Port NorPort
FDA UDI
Class IIActive
Valved Introducer Flowguard
FDA UDI
Class IIActive
Clear-View MAX "Sub-Q" Infusion Set ClearView™MAX
FDA UDI
Class IIActive
Clear-View Subcutaneous Infusion Set Clear-View "Sub-Q"
FDA UDI
Class IIActive
TidalPort Vascular Access Port TidalPort
FDA UDI
Class IIActive
Clear-View Multi-site Subcutaneous Infusion Set ClearView™MS
FDA UDI
Class IIActive

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