LUXSHARE - ICT (NGHE AN ) LIMITED

FDA Device Registration & Listing · Nghe An, VN · Registration 3018514222

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
3018514222
FEI Number
3018514222
Entity Name
LUXSHARE - ICT (NGHE AN ) LIMITED
City/State/Country
Nghe An, VN
Establishment Address
No.18.03 Street, VSIP Nghe An Industrial Park, Hung Nguyen Commune, Nghe An Province, Viet Nam, Nghe An 880000, VN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
LUXSHARE - ICT (NGHE AN ) LIMITED (Owner Number: 10093365)
Owner / Operator Contact Address
No.18.03 Street, VSIP Nghe An Industrial Park, Hung Nguyen Commune, Nghe An Province, Viet Nam, Nghe An, VN-22 880000, VN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Pulse Oximeter MD300C228-H-D3 HCSM70T Pulse Oximeter MD300C53 HCSM70P Pulse Oximeter MD300CN130-D4 2200 Pulse Oximeter MD300CN386 iP900AP Pulse Oximeter MD300CN310-D4 2100 Pulse Oximeter MD300C1J Purple 500L Pulse Oximeter MD300C1J Pink 500L Pulse Oximeter MD300C1J Black 500L Pulse Oximeter MD300CN320R Pulse Oximeter MD300CN568R Fingertip Pulse Oximeter MD300CI218R Smart Pulse Oximeter OX200 Pulse Oximeter MD300CN330R Fingertip Pulse Oximeter MD300CN340R Pulse Oximeter MD300CN550R Pulse Oximeter MD300C205 Fingertip Pulse Oximeter MD300C29 Fetal Spiral Electrode Cable Fingertip Pulse Oximeter MD300C57 Fingertip Pulse Oximeter MD300C53 Fingertip Pulse Oximeter MD300CN368R Fingertip Pulse Oximeter MD300CN160 Pulse Oximeter OxyWatch C205 Fingertip Pulse Oximeter MD300CN340 Fingertip Pulse Oximeter OxyWatch C29 Fingertip Pulse Oximeter MD300C55 Fingertip Pulse Oximeter MD300C56 Fingertip Pulse Oximeter MD300CI218R Fingertip Pulse Oximeter MD300C29 Fingertip Pulse Oximeter OxyWatch C20 Fingertip Pulse Oximeter MD300CN140 Fingertip Pulse Oximeter OxyWatch C1F Pulse Oximeter MD300CN510 eufy Wearable Breast Pump S1 (T8D02) eufy Wearable Breast Pump E10 (T8D03) Pulse Oximeter MD300C52 BJ240120 Pulse Oximeter MD300C21C 16-93651 Pulse Oximeter MD300C2B 12-1927 Pulse Oximeter MD300C52-H-D2 2150 Pulse Oximeter MD300C1D 16-FTP Pulse Oximeter MD300C15 ASP300C15 Pulse Oximeter MD300C12 459-ROW Pulse Oximeter MD300C1B 12-1926 Pulse Oximeter MD300CN310 PM-DC40040 Pulse Oximeter MD300C12 459-HKW Pulse Oximeter MD300C2J6 500C Pulse Oximeter MD300C17 B240100 Pulse Oximeter MD300CN310 2711-30310 Pulse Oximeter CN360 HCSM70S Pulse Oximeter MD300C1K 500CL Pulse Oximeter MD300C12 459-GYW MD300C12 Pulse Oximeter 459-PUW Pulse Oximeter MD300C634 570-3222 Pulse Oximeter MD300C21C 081505965 Pulse Oximeter MD300C12 459-BKW Pulse Oximeter MD300C53 18707 Pulse Oximeter MD300C12 459-REW Pulse Oximeter MD300C53-H-D2 12-1935 Pulse Oximeter MD300C52 300A Vital Signs Monitor MD2000C SpO2 probe M-50H 16-2356 SpO2 probe M-50J033 16-2352 Pulse Oximeter MD300M 16-835V2 SpO2 probe M-50C 16-2350 Pulse Oximeter MD300M-G HCSMD400 Pulse Oximeter MD300K2 900-8275 SpO2 probe M-50J037 16-2353 SpO2 probe M-50B 16-2358 SpO2 probe M-50E 16-2351 SpO2 probe M-50J035 16-2354 Pulse Oximeter MD300M 16-834V2 Pulse Oximeter MD300C238 iP900BP-B Pulse Oximeter MD300C218 500E-B

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2025-05-14
DQA Oximeter Cardiovascular Class 2 870.2700 2025-05-14
DQA Oximeter Cardiovascular Class 2 870.2700 2025-05-14
DQA Oximeter Cardiovascular Class 2 870.2700 2025-05-14
PGJ Oximeter, Wellness Cardiovascular Class 2 870.2700 2025-05-23
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2025-05-06
OCH Oximeter, Infrared, Sporting, Aviation Cardiovascular Class 2 870.2700 2025-05-23
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2026-05-28
DQA Oximeter Cardiovascular Class 2 870.2700 2025-05-14
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2025-05-14
DQA Oximeter Cardiovascular Class 2 870.2700 2025-05-14
DQA Oximeter Cardiovascular Class 2 870.2700 2025-05-14

Official Correspondent

Snowy Shi

US Agent Details

Austin Chen Business: Austin Chen Email: austin.chen@luxshare-ict.com Phone: (408) 9570535

Related Public Records

Same Entity

LUXSHARE - ICT (NGHE AN ) 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
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018514222. Last updated year: 2026. Please use registration number 3018514222 when referencing this establishment in official correspondence.
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