ATOM HEALTH CORPORATION

FDA Device Registration & Listing · Tainan City, TW · Registration 3014498861

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
3014498861
FEI Number
3014498861
Entity Name
ATOM HEALTH CORPORATION
City/State/Country
Tainan City, TW
Establishment Address
1F., No. 29, Minsheng 6th St., Guiren Dist.,, Tainan City 711009, TW
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
ATOMHEALTH Corporation (Owner Number: 10057545)
Owner / Operator Contact Address
4FL.-3, No.112, Sec.2, Zhongshan North Road, Zhongshan Dist., Taipei City, TW-TPE 104, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

CompactCath MOCACARE CompactCath CompactCath MOCACARE MOCACARE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FAQ Bag, Urine Collection, Leg, For External Use, Sterile Gastroenterology, Urology Class 1 876.5250 2022-11-11
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2018-12-18
NZU Collector, Urine, Powered, Non Indwelling Catheter Gastroenterology, Urology Class 1 876.5250 2026-04-13
FCN Urinary Drainage Collection Kit, For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2022-11-11
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2018-12-18
EZC Catheter, Coude Gastroenterology, Urology Class 2 876.5130 2018-12-18
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2020-05-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-09-24

Official Correspondent

No official correspondent registered.

US Agent Details

Bill Reverman Email: bill@compactcath.com Phone: (503) 5473339

Related Public Records

Same Entity

ATOMHEALTH Corporation
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-0004-2013 Cure Medical LLC 2
Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014498861. Last updated year: 2026. Please use registration number 3014498861 when referencing this establishment in official correspondence.
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