ZOE MEDICAL, INC.

FDA Device Registration & Listing · TOPSFIELD, MA, US · Registration 3003294644

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
3003294644
FEI Number
3003294644
Entity Name
ZOE MEDICAL, INC.
City/State/Country
TOPSFIELD, MA, US
Establishment Address
460 BOSTON ST., TOPSFIELD, MA 01983, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Zoe Medical, Inc (Owner Number: 9041242)
Owner / Operator Contact Address
460 BOSTON ST., --, Topsfield, MA 01983, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K130740
PMA Number
N/A

All Registered Proprietary Names

Ultraview DM3 Schiller DS20 Midmark DVSD Midmark IQvitals Nightingale PPM3 Nightingale MPC Nightingale Monitoring System PPM3

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 2010-04-14
DQA Oximeter Cardiovascular Class 2 870.2700 2010-04-14
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2024-12-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-12-12
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2013-12-30

Official Correspondent

Bengt Hermanrud

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Zoe Medical, Inc
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.
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003294644. Last updated year: 2026. Please use registration number 3003294644 when referencing this establishment in official correspondence.
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