MEMO Patch M (MPT-E08R-UNC01)
K-Number: K243438 · 2025-12-05
ApplicantHuinno Co., Ltd.
Decision Date2025-12-05
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
MEMO Patch M (MPT-E08R-UNC01) is a medical device manufactured by Huinno Co., Ltd.. It received FDA 510(k) clearance on 2025-12-05 under approval number K243438. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MEMO Patch M (MPT-E08R-UNC01)?
MEMO Patch M (MPT-E08R-UNC01) is a medical device that received FDA 510(k) clearance on 2025-12-05. It is manufactured by Huinno Co., Ltd.. The 510(k) number is K243438.
When was MEMO Patch M (MPT-E08R-UNC01) approved by the FDA?
MEMO Patch M (MPT-E08R-UNC01) received FDA 510(k) clearance on 2025-12-05, under approval number K243438.
What company makes MEMO Patch M (MPT-E08R-UNC01)?
MEMO Patch M (MPT-E08R-UNC01) is manufactured by Huinno Co., Ltd..
What is the FDA product code for MEMO Patch M (MPT-E08R-UNC01)?
The FDA product code for MEMO Patch M (MPT-E08R-UNC01) is DXH. This falls under the Hematology category.
Related Devices (Code: DXH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.