FDA 510(k)

Verifine 安全采血针

K号: K261045 · 2026-05-01

申请人Promisemed Hangzhou Meditech Co., Ltd.

决定日期2026-05-01

产品代码FMK

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决定实质等同

器械摘要

Verifine Safety Lancets is the device name listed in this FDA 510(k) record. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K261045. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Verifine Safety Lancets?

Verifine Safety Lancets is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K261045.

When did Verifine Safety Lancets receive FDA 510(k) clearance?

Verifine Safety Lancets received FDA 510(k) clearance on 2026-05-01, under 510(k) number K261045.

Who is the listed applicant for Verifine Safety Lancets?

FDA 510(k)记录将杭州普瑞美德医疗科技有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Verifine Safety Lancets?

The FDA product code for Verifine Safety Lancets is FMK.

列明Promisemed Hangzhou Meditech Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261719Promisemed X 安全笔式针头 K261196Promisemed VeriEcto 自动活检针 K254273Verisafe 安全无菌针（SSN）K250192Verisafe 安全可缩回胰岛素注射器 K250961血液采集管夹 K251138Promisemed 安全胡伯针

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。