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Verisafe Safety Retractable Insulin Syringes

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K250192

by Promisemed Hangzhou Meditech Co., Ltd.

Identifiers

510(k) Number
K250192 FDA 510(k)
FDA Product Code
FMF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5860 FDA 510(k)
Regulation Number
880.5860 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Verisafe Safety Retractable Insulin Syringes are a type of Syringe, Piston designed for the safe administration of insulin. These devices incorporate a retractable needle mechanism to minimise post-injection exposure risk, ensuring enhanced user safety during handling and disposal.

Intended for single-use in clinical and home settings, these syringes are classified under Product Code FMF and comply with FDA 510(k) clearance (K250192) and MDR requirements. Supplied sterile, they require no additional processing before use and are regulated under General Hospital (HO) Subpart F guidelines. No MRI safety or reusable specifications are indicated.

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: Verisafe Safety Retractable Insulin Syringes (K250192) — FDA 510 (k ..., Verisafe Safety Retractable Insulin Syringes - FDA 510(k) K250192, K250192 FDA 510(k) - Verisafe Safety Retractable Insulin Syr..., Promisemed

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) K250192 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026