NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD.

FDA Device Registration & Listing · Cixi Zhejiang, CN · Registration 3017178358

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
3017178358
FEI Number
3017178358
Entity Name
NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD.
City/State/Country
Cixi Zhejiang, CN
Establishment Address
No.188 Binjiang Road,Cixi High-tech Industrial Development Zone, Cixi City, Zhejiang, 315301, P.R.China, Cixi Zhejiang 315301, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Ningbo Xinwell Medical Technology Co., Ltd. (Owner Number: 10075092)
Owner / Operator Contact Address
No.188 Binjiang Road, Cixi High-tech Industrial Development Zone, Cixi City, 315301, Zhejiang,P.R.China, Cixi, CN-ZJ 315301, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

blood pressure cuff Video laryngoscope Hemostatic Metal Clip For The Gi Tract-Disposable Hemostatic Clips Patient monitoring Cables for ECG, EKG, SpO2 and Blood Pressure Monitors Circuit, breathing (w connector, adaptor, y piece) CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) MASK, GAS, ANESTHETIC All Ceramic Polishers FlexiPoints MASS SPECTROMETRY MONITORING LINE CONONECTORS Disposable Injection Needles Disposable biopsy forceps

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2020-06-08
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2021-04-22
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2024-06-16
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2020-06-08
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 2020-06-07
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2020-06-08
BSJ Mask, Gas, Anesthetic Anesthesiology Class 1 868.5550 2021-12-27
EHL Point, Abrasive Dental Class 1 872.6010 2008-11-12
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2025-04-18
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-04-17
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2021-09-12

Official Correspondent

Lei Xi

US Agent Details

Wen Xu Email: infor@believe-med.com Phone: (443) 8968583

Related Public Records

Same Entity

Ningbo Xinwell Medical Technology Co., Ltd.
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
K831001 Frontier Products UNICUFF-BLOOD PRESSURE CUFF 1983-07-28
K253089 Shenzhen Best Electronics Co., Ltd. NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) 2026-02-13
K972301 Rudolf Riester GmbH & Co. KG BIG BEN SQUARE, BIG BEN ROUND 1997-09-17
K880323 Medtronic Vascular MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR 1988-03-22
K142467 Abeon Medical Corporation IntelAir Nasal Airway Support System 2014-11-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0144-2024 Covidien 1
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0033-04 VIASYS Med Systems 1
Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04 VIASYS Med Systems 1
Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017178358. Last updated year: 2026. Please use registration number 3017178358 when referencing this establishment in official correspondence.
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