UAN Healthcare Limited

FDA Device Registration & Listing · CENTRAL, HK · Registration 3043013796

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
3043013796
FEI Number
3043013796
Entity Name
UAN Healthcare Limited
City/State/Country
CENTRAL, HK
Establishment Address
FLAT/RM 502 5/F THE L.PLAZA NOS., 367-375 QUEENS ROAD, CENTRAL 999077, HK
Establishment Type(s)
Foreign Private Label Distributor
Owner / Operator
UAN HEALTHCARE LIMITED (Owner Number: 10094761)
Owner / Operator Contact Address
FLAT/RM 502 5/F THE L.PLAZA NOS. 367-375 QUEEN'S ROAD, CENTRAL, HK-NOTA 999077, HK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

AUVON, BLOOD GLUCOSE TEST STRIPS & STERILE LANCETS, model DS-W AUVON, BLOOD GLUCOSE MONITORING SYSTEM, model DS-W AUVON, Lancing Device & Twist Lancets AUVON, STERILE LANCETS AUVON, Adhesive Electrodes, model EP3M12 AUVON, Adhesive Electrodes, model EB1520 AUVON, Adhesive Electrodes, model EB1010 AUVON, Adhesive Electrodes, model EB1M20 AUVON, Adhesive Electrodes, model EB1548 AUVON, Adhesive Electrodes, model EB1024 AUVON, Adhesive Electrodes, model EB1M36 AUVON, BLOOD GLUCOSE MONITORING SYSTEM, model DS-W AUVON, BLOOD GLUCOSE TEST STRIPS & STERILE LANCETS, model DS-W AUVON, BLOOD GLUCOSE TEST STRIPS, model DS-W AUVON, Electrode Lead Wires, model LW142A AUVON, Electrode Lead Wires, model LW1402 AUVON, Wireless TENS & EMS Unit, model TX6224 AUVON, Pressure relief wheelchair cushion, model SW6321 AUVON, Wheelchair Seat Cushions, model SC11111 AUVON, Anti-Slip Wheelchair Cushions, model SW4111 AUVON, Ventilation Seat Cushion, model SW6412 AUVON, Cooling Gel Wheelchair Seat Cushion, model SW6652 AUVON, Gel seat cushion, model SW1651 AUVON, SACRUM SILICONE FOAM DRESSING, model SAH0710 AUVON, Silicone Foam Dressing, model SAS0310 AUVON, SACRUM SILICONE FOAM DRESSING, model SAH0705 AUVON, SILICONE FOAM DRESSING, model SAS0407 AUVON, Silicone Foam Dressing, model SAS0322 AUVON, SILICONE FOAM DRESSING, model SAS0412 AUVON, SILICONE FOAM DRESSING, model SAS0422 AUVON, Silicone Foam Dressing, model SAS0603 AUVON, TENS AND EMS (TENS and Muscle Stimulator), model JT8012C AUVON, TENS AND EMS (TENS and Muscle Stimulator), model JT8016 AUVON, Conductive Gel, model CG2252 AUVON, TENS and EMS Unit, model TC3241 AUVON, OTC 4-Channel Rechargeable TENS Unit, model TP2408C AUVON, Tens & Ems Device, model TU1080 AUVON, OTC TENS & EMS Unit, model TA2224 AUVON, OTC TENS & EMS Unit, model TA3224 AUVON, OTC TENS & EMS Unit, model TU2424 AUVON, Muscle and Nerve Stimulator TENS & EMS, model TP2208 AUVON, Muscle and Nerve Stimulator TENS & EMS, model TP2208C AUVON, Pill Splitter, model PS1111 AUVON, lumbar pillow, model WO2121

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2025-12-22
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2025-12-22
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2025-12-22
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2025-12-22
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2025-12-22
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2026-06-02
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2025-12-22
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2025-12-22
IMP Cushion, Wheelchair Physical Medicine Class 1 890.3920 2025-12-22
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2025-12-22
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2025-12-22
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2025-12-22
GYB Media, Electroconductive Neurology Class 2 882.1275 2025-12-22
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2025-12-22
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2025-12-22
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2025-12-22
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2025-12-22
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2025-12-22
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2025-12-22
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2025-12-22
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2025-12-22
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2025-12-22
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2025-12-22
OHY Pill Crusher/Cutter General Hospital Class 1 880.6430 2025-12-22
IQE Orthosis, Lumbar Physical Medicine Class 1 890.3490 2025-12-22

Official Correspondent

Charlie Chen

US Agent Details

Simin Lin Email: simin_lin123@126.com Phone: (415) 6026843

Related Public Records

Same Entity

UAN HEALTHCARE LIMITED
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
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24
K073532 Technomed Europe DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES 2008-05-01
K260363 Ceribell, Inc. Ceribell Brain Monitor Headband 2026-04-03
K091762 Covidien DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE 2009-12-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0378-06 Instrumentation Laboratory Co. 2
GEM PREMIER 3000
Z-2165-2011 Instrumentation Laboratory Co. 2
Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus
Z-0004-2009 Lifescan Inc 2
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06 Abbott Laboratories Medisense Products 2
FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06 Abbott Laboratories Medisense Products 2
Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

Similar Registrations

Registration Number Establishment Name Location
3007382160 i-SENS Wonju Factory Wonju-si Gangwon, KR
3006755541 BIONIME USA CORPORATION Ontario, CA, US
8031690 ASAHI POLYSLIDER COMPANY, LIMITED Okayama-Kuse Plant Maniwa Okayama, JP
3011806823 Roche Diabetes Care GmbH Mannheim Baden-Wurttemberg, DE
3008789114 PRODIGY DIABETES CARE, LLC Huntersville, NC, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043013796. Last updated year: 2026. Please use registration number 3043013796 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.