AKTIIA SA

FDA Device Registration & Listing · Neuchatel, CH · Registration 3019575688

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3019575688
FEI Number
3019575688
Entity Name
AKTIIA SA
City/State/Country
Neuchatel, CH
Establishment Address
Rue du Bassin 8a,, Neuchatel 2000, CH
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Aktiia SA (Owner Number: 10092031)
Owner / Operator Contact Address
Rue du Bassin 8a,, Neuchatel, CH-NE 2000, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K250415
PMA Number
N/A

All Registered Proprietary Names

Hilo Cuff G0 Blood Pressure Monitoring System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2026-02-11

Official Correspondent

NEIL PURI

US Agent Details

Neil Puri Business: Neil Puri Email: neil.puri@aktiia.com Phone: (808) 2844774

Related Public Records

Same Entity

Aktiia SA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24
K952827 Sein Electronics Co., Ltd. FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 1996-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019575688. Last updated year: 2026. Please use registration number 3019575688 when referencing this establishment in official correspondence.
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