Profoject™ Dual-Safety Pen Needles
K号: K261829 · 2026-07-29
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器械摘要
Profoject™ Dual-Safety Pen Needles is the device name listed in this FDA 510(k) record. The listed applicant is CMT Health PTE., Ltd.. It received FDA 510(k) clearance on 2026-07-29 under 510(k) number K261829. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Profoject™ Dual-Safety Pen Needles?
Profoject™ Dual-Safety Pen Needles is a medical device that received FDA 510(k) clearance on 2026-07-29. The listed applicant is CMT Health PTE., Ltd.. The 510(k) number is K261829.
When did Profoject™ Dual-Safety Pen Needles receive FDA 510(k) clearance?
Profoject™ Dual-Safety Pen Needles received FDA 510(k) clearance on 2026-07-29, under 510(k) number K261829.
Who is the listed applicant for Profoject™ Dual-Safety Pen Needles?
The FDA 510(k) record lists CMT Health PTE., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Profoject™ Dual-Safety Pen Needles?
The FDA product code for Profoject™ Dual-Safety Pen Needles is FMI.
相关临床试验
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列明CMT Health PTE., 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。
K262215Profoject™ Safety Sliding Blood Collection SetK261372Profoject™ LOR SyringeK260739Profoject™ Pen Needles (Model A; Model B)K260514Profoject™ 安全针；Profoject™ 带安全针的注射器；Profoject™ 低死腔注射器带安全针K260855Profoject™ 安全笔针K253268Profoject 鼻饲/口饲注射器；Profoject 可重复使用鼻饲/口饲注射器（型号A，型号B）；Profoject ENFit 连接器；Profoject 鼻饲注射器盖
相关器械（代码：FMI）
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。
K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X 安全笔式针头Promisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.K260855Profoject™ 安全笔针CMT Health PTE., Ltd.
官方来源
在 FDA 数据库中查看 →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。
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