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Intervene Group Limited

US

Last updated May 25, 2026

What Intervene Group Limited makes

The company manufactures single-use medical devices for medication transfer, anaesthesia, and epidural procedures, including filtering needles, protective caps, conduction filters, and intrathecal anaesthesia sets. Products like the Dash 6 series serve as needle guides, medication transfer needles, and NRFit-formatted connectors for epidural and catheter applications. These devices are designed to reduce contamination risk and improve procedural safety in clinical settings.

All listed devices fall under FDA Class II regulation and are authorised via 510(k) clearance and the FDA’s Unique Device Identification (UDI) system. The portfolio is registered in the FDA’s 510(k) and UDI databases, ensuring compliance with US medical device requirements. The manufacturer operates from 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 Intervene Group Limited manufacture?

Intervene Group Limited specialises in single-use medical devices primarily for medication transfer, anaesthesia, and epidural procedures. Their portfolio includes filtering needles for medication transfer, NRFit-formatted protective caps and connectors for epidural/catheter applications, anaesthesia conduction filters, and intrathecal anaesthesia sets. These devices are designed to enhance procedural safety by minimising contamination risks.

Where is Intervene Group Limited based, and how does that affect its regulatory compliance?

Intervene Group Limited is based in the United States, which means its devices must comply with FDA regulations. Since all listed devices fall under FDA Class II classification, they are authorised through the 510(k) clearance process and the FDA’s Unique Device Identification (UDI) system. This ensures their devices meet US safety and performance standards.

Which regulatory registries list Intervene Group Limited’s devices?

Intervene Group Limited’s devices are registered in the FDA’s 510(k) and UDI databases. These registries confirm that the devices have undergone the necessary authorisation processes—specifically 510(k) clearance for Class II devices—and comply with the FDA’s Unique Device Identification requirements.

How are Intervene Group Limited’s devices classified under FDA regulations?

All of Intervene Group Limited’s listed devices are classified as FDA Class II. This classification applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. The 510(k) clearance process is used to demonstrate that these devices meet those regulatory requirements.

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

Information

Country
US
Address
—
Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
735285129

Catalogue (42)

DeviceModel / ReferenceRegistriesClassStatus
Dash 6 15041001
FDA UDI
Class IIActive
Dash 6 15171001
FDA UDI
Class IIActive
Dash 6 15011200
FDA UDI
Class IIUnknown
Dash 6 15020010
FDA UDI
Class IIUnknown
Dash 6 15011100
FDA UDI
Class IIUnknown
Dash 6 15021200
FDA UDI
Class IIUnknown
Dash 6 15111001
FDA UDI
Class IIActive
Dash 6 15010050
FDA UDI
Class IIUnknown
Dash 6 15011030
FDA UDI
Class IIUnknown
Dash 6 15290050
FDA UDI
Class IIActive
Dash 6 15010200
FDA UDI
Class IIUnknown
Dash 6 15300001
FDA UDI
Class IIActive
Dash 6 15491050
FDA UDI
Class IIActive
Dash 6 15011600
FDA UDI
Class IIUnknown
Dash 6 15020050
FDA UDI
Class IIUnknown
Dash 6 15490050
FDA UDI
Class IIActive
Dash 6 15021050
FDA UDI
Class IIUnknown
Dash 6 15231022
FDA UDI
Class IIActive
Dash 6 15021010
FDA UDI
Class IIUnknown
Dash 6 15010600
FDA UDI
Class IIUnknown
Dash 6 NRFit™ 15090002
FDA UDI
Class IIActive
Dash 6 15021030
FDA UDI
Class IIUnknown
Dash 6 15280100
FDA UDI
Class IIActive
Dash 6 15011010
FDA UDI
Class IIUnknown
Dash 6 15200001
FDA UDI
Class IIActive
Dash 6 15010100
FDA UDI
Class IIUnknown
Dash 6 15310022
FDA UDI
Class IIActive
Dash 6 15010030
FDA UDI
Class IIUnknown
Dash 6 15311022
FDA UDI
Class IIActive
Dash 6 15110001
FDA UDI
Class IIActive
Dash 6 15020200
FDA UDI
Class IIUnknown
Dash 6 15020030
FDA UDI
Class IIUnknown
Dash 6 15011050
FDA UDI
Class IIUnknown
Dash 6 15291050
FDA UDI
Class IIActive
Dash 6 15040001
FDA UDI
Class IIActive
Dash 6 15161001
FDA UDI
Class IIActive
Dash 6 15010010
FDA UDI
Class IIUnknown
Dash 6 15021100
FDA UDI
Class IIUnknown
Dash 6 15020100
FDA UDI
Class IIUnknown
Dash 6 15281100
FDA UDI
Class IIActive
DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories K170900
FDA 510(k)
Class IIActive
DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe K170371
FDA 510(k)
Class IIActive

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