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Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K161950

by Promisemed Hangzhou Meditech Co., Ltd.

Identifiers

510(k) Number
K161950 FDA 510(k)
FDA Product Code
FMI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5570 FDA 510(k)
Regulation Number
880.5570 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Verifine Safety Insulin Pen Needle is a safety-type insulin pen needle (product code FMI) designed to minimize needlestick injuries during insulin administration. It features an automatic shielding mechanism to retract and secure the needle after use, reducing exposure risk while maintaining compatibility with standard insulin pen devices.

This single-use device is supplied in sterile packaging and is intended for manual insertion into the skin. Available in lengths of 4–8 mm and gauges 29–31G, it adheres to FDA 510(k) clearance (K161950) and MDR compliance. Storage requires adherence to manufacturer guidelines to preserve sterility and functionality.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Verifine® Safety Insulin Pen Needles | Auto-Shield | 4-8 mm, 29-31G ..., Insulin Pen Needles Manufacturer | Promisemed, Promisemed, DEVICE: Verifine® Safety Type Insulin Pen Needle (36971227400117)

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Promisemed Hangzhou Meditech Co., Ltd.

Sources (2)

  • FDA 510(k) K161950 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026