SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3012797688

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
3012797688
FEI Number
3012797688
Entity Name
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
401, 501, Building 4, Haizhi Technology Park, Fortis, No. 17, Bulan Road,, Xialilang Community, Nanwan Street, Longgang District,, Shenzhen Guangdong 518112, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shenzhen HugeMed Medical Technical Development Co., Ltd (Owner Number: 10052108)
Owner / Operator Contact Address
401, 501, Building 4, Haizhi Technology Park, Fortis, No.17, Bulan Road,, Xialilang Community, Nanwan Street, Longgang District,, Shenzhen, CN-GD 518112, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Single-use Bronchoscope BR-M58, BR-M52, BR-M50, BR-M40, BR-M32, BR-M22, BR-M25, BR-M58H, BR-M52H, BR-M40H,BR-M42,BR-M30; Image Processor VLM-02, VLM-03, MS-8, HUV-02 Stone Collector 140mL-S, 180mL-L I-DLP-05BD-40AM-0100, I-DLP-05BD-40AM-0100, I-DLP-06AD-40AM-0100, I-DLP-05AM-40AM-0100, I-DLP-05AM-40AM-0100, I-DLP-05BM-40AM-0100, I-DLP-06AF-MXAN-0100, I-DLP-06BF-MXAN-0100, I-DLP-06BF-MXAN-0100, I-DLP-03BK-40AS-0100, I-DLP-05AK-40AS-0100, I-DLP-05AK-40AS-0100, I-DLP-05AV-40AS-0100, I-DLP-05BV-40AS-0100, I-DLP-05BV-40AS-0100, I-DLP-03BF-36AN-0100, I-DLP-03BF-36AN-0100, I-DLP-06AF-MXAN-0100, I-DLP-05AL-40AT-0100, I-DLP-05BL-40AT-0100, I-DLP-05BL-40AT-0100, I-DLP-A0003D05-001, I-DLP-A0003D05-001, I-DLP-A0003D05, I-DLP-A0003D05 I-DLP-05BM-40AM-0100, I-DLP-03AF-36AN-0100, I-DLP-03AF-36AN-0100, I-DLP-03AK-40AS-0100, I-DLP-03AK-40AS-0100, I-DLP-03BK-40AS-0100, I-DLP-05BK-40AS-0100, I-DLP-05BK-40AS-0100, I-DLP-05AV-40AS-0100, I-DLP-05AB-40AS-0100, I-DLP-05BB-40AS-0100, I-DLP-05BB-40AS-0100, I-DLP-03AD-40AM-0100, I-DLP-03AD-40AM-0100, I-DLP-03BD-40AM-0100, I-DLP-03BD-40AM-0100, I-DLP-05AD-40AM-0100, I-DLP-05AD-40AM-0100, I-DLP-03BB-40AS-0100, I-DLP-03BB-40AS-0100, I-DLP-05AB-40AS-0100, I-DLP-05BC-40AT-0100, I-DLP-05BC-40AT-0100, I-DLP-05AL-40AT-0100, I-DLP-06AD-40AM-0100, I-DLP-06BD-40AM-0100, I-DLP-06BD-40AM-0100, I-DLP-05AU-40AS-0100, I-DLP-05AU-40AS-0100, I-DLP-05BU-40AS-0100, I-DLP-05BU-40AS-0100, I-DLP-03AB-40AS-0100, I-DLP-03AB-40AS-0100, I-DLP-03AC-40AT-0100, I-DLP-03AC-40AT-0100, I-DLP-03BC-40AT-0100, I-DLP-03BC-40AT-0100, I-DLP-05AC-40AT-0100, I-DLP-05AC-40AT-0100, Single-use Ureteral Access Sheath Y-08-36, Y-08-40, Y-08-45, Y-08-50, Y-08-55, Y-09-36, Y-09-40, Y-09-45, Y-09-50, Y-12-45, Y-12-50, Y-12-55 Y-09-55, Y-10-36, Y-10-40, Y-10-45, Y-10-50, Y-10-55, Y-11-36, Y-11-40, Y-11-45, Y-11-50, Y-11-55, Y-12-36, Y-12-40, VL3R / VL3D VLDM-01;VLDM-02;VLDM-03;VLDM-04; VL3D plus VLRM;VLDM VL4R,VL4D VL3N, VL4N, VL4REX, VL4DEX, VL3REX, VL3DEX Disposable Stone Retrieval Basket BS-3P-0612/11, BS-3P-0712/08, BS-3P-0712/11, BS-4P-0612/10, BS-4P-0612/16 BS-3P-5312/08, BS-3P-5312/11, BS-3P-0612/08 Single-use Biliary Pancreaticobiliary Scope CL-A, CL-B; Image Processor HUV-02 Single-use Cystoscope CY-M52, CY-M50, CY-M40, CY-M32,CY-M52H, CY-M40H; Image Processor HUV-01,VLM-03, MS-8, HUV-02; Image Processor HUV-01, HUV-02, VLM-03, MS-8 Single-use Choledochoscope CH-M50, CH-M52, CH-M40, CH-M32, CH-M40H, CH-M52H, Medical Display,HM -01, HMT-01 Broncho Sampler BS01 I-TCB-05MD-10AS-0030, I-MCB-03MA-10AS-0030, I-MCB-03MB-10AS-0030, I-MCB-05MA-10AS-0030, I-TCB-01EP-04AS-0000, I-TCB-01EP-15AS-0000, I-MCB-03NA-10AS-0010, I-MCB-03NB-10AS-0010, I-RLW-10BN-MXAS-0001, I-RLW-10CN-MXAS-0001, I-RLW-04CN-29AS-0001, I-LDW-3552-001, I-RLW-05BD-29LA-0000, I-RLW-05BD-29LL-0000, I-RLW-05BD-29RA-0000, I-RLW-05BD-29RL-0000, I-RLW-05BD-29VX-0000, I-RLW-05BD-51LA-0000, I-RLW-05BD-51LL-0000, I-RLW-05BD-51RA-0000, I-RLW-05AC-40RA-0000, I-RLW-05AC-40RL-0000, I-RLW-05AC-40VX-0000, I-RLW-05BC-24LA-0000, I-RLW-10BC-40AS-0000, I-RLW-05AC-24LA-0000, I-RLW-05AC-24LL-0000, I-RLW-05AC-24RA-0000, I-RLW-05BC-40LA-0000, I-RLW-05BC-40LL-0000, I-RLW-05BC-40RA-0000, I-RLW-05BC-40RL-0000, I-MCB-05MB-10AS-0030, I-RLW-03AC-24AS-0000, I-RLW-03AC-40AS-0000, I-RLW-03BC-24AS-0000, I-RLW-03AK-39AS-0000, I-RLW-03BK-39AS-0000, I-RLW-05AK-39AS-0000, I-RLW-05BK-39AS-0000, I-SLC-4100-510, I-SLC-4100 I-RLW-06AD-51AS-0000, I-RLW-06AD-MXAS-0000, I-RLW-06BD-29AS-0000, I-RLW-06BD-51AS-0000, I-TCB-05JD-10AS-0020, I-TCB-03JK-10AS-0020, I-TCB-05JK-10AS-0020, I-TCB-10JK-10AS-0020, I-RLW-05AC-24RL-0000, I-RLW-05AC-24VX-0000, I-RLW-05AC-40LA-0000, I-RLW-05AC-40LL-0000, I-TCB-06VF-10AS-0000, I-MCB-03VA-10AS-0100, I-MCB-03VB-10AS-0100, I-MCB-06VA-10AS-0110, I-LDW-03BB-51AS-0100, I-RLW-03BB-63AS-0000, I-LDW-05AB-29AS-0100, I-RLW-05AB-39AS-0000, I-LDW-03AB-51AS-0100, I-RLW-03AB-63AS-0000, I-LDW-03BB-29AS-0100, I-RLW-03BB-39AS-0000, I-MCB-03JA-10AS-0020, I-MCB-03JB-10AS-0020, I-MCB-05JA-10AS-0020, I-MCB-05JB-10AS-0020, I-RLW-05AL-24V4-0000, I-RLW-05AL-24V5-0000, I-RLW-05AL-24V6-0000, I-RLW-05AM-29V2-0000, I-RLW-05AL-40V2-0000, I-RLW-05AL-40V3-0000, I-RLW-05AL-40V4-0000, I-RLW-05AL-40V5-0000, I-RLW-05BD-29AS-0000, I-RLW-05BD-51AS-0000, I-RLW-05BD-MXAS-0000, I-RLW-06AD-29AS-0000, I-LW-2090040/5A, I-LW-3090018/5A, I-LW-3090024/5A, I-LW-3090040/5A, I-SLC-4100-310, I-SLC-4100-410, I-RLW-05AD-51LL-0000, I-RLW-05AD-51RA-0000, I-RLW-05AD-51RL-0000, I-RLW-05AD-51VX-0000, I-RLW-03AW-51AS-0000, I-RLW-03BW-29AS-0000, I-RLW-03BW-51AS-0000, I-RLW-05AW-29AS-0000, I-CB-72540R, I-CB-72307R, I-CB-72507R, I-CB-72521R, I-LW-2090018/3A, I-LW-2090024/3A, I-RLW-05AU-34AS-0000, I-RLW-05BU-34AS-0000, I-LDW-03AB-29AS-0100, I-RLW-03AB-39AS-0000, I-MCB-06VB-10AS-0110, I-RLW-06BF-MXAS-0000, I-TCB-03MA-10AS-0030, I-TCB-05MA-10AS-0030, I-RLW-03BC-40AS-0000, I-RLW-05AC-24AS-0000, I-RLW-05AC-40AS-0000, I-RLW-05BC-24AS-0000, I-TCB-05ND-10AS-0000, I-TCB-05ND-20AS-0000, I-CBT-10NR-10CM-0001, I-TCB-10DN-08AS-0030, I-RLW-05BM-29V4-0000, I-RLW-05BM-29V5-0000, I-RLW-05BM-29V6-0000, I-RLW-05BL-40V2-0000, I-LDW-05BB-29AS-0100, I-LDW-05BB-51AS-0100, I-LDW-05BB-MXAS-0100, I-RLW-05BB-39AS-0000, I-RLW-05BD-51RL-0000, I-RLW-05BD-51VX-0000, I-RLW-05AL-24V2-0000, I-RLW-05AL-24V3-0000, I-TCB-03MB-10AS-0030, I-TCB-05MB-10AS-0030, I-TCB-03MC-10AS-0030, I-TCB-05MC-10AS-0030, I-RLW-03AY-34AS-0000, I-RLW-03BY-34AS-0000, I-RLW-05AY-34AS-0000, I-RLW-05BY-34AS-0000, I-RLW-05AK-MXAS-0000, I-RLW-05BK-MXAS-0000, I-RLW-05AV-39AS-0000, I-RLW-05BV-39AS-0000, I-RLW-05BC-24LL-0000, I-RLW-05BC-24RA-0000, I-RLW-05BC-24RL-0000, I-RLW-05BC-24VX-0000, I-RLW-05AB-63AS-0000, I-RLW-05AB-MXAS-0000, I-LDW-05AB-51AS-0100, I-LDW-05AB-MXAS-0100, I-RLW-05BR-51AS-0000, I-RLW-05AD-29AS-0000, I-RLW-05AD-51AS-0000, I-RLW-05AD-MXAS-0000, I-LW-2090040/3A, I-LW-3090024/3A, I-LW-3090040/3A, I-LW-2090018/5A, I-LW-2090024/5A, I-RLW-06AY-34AS-0000, I-RLW-06BY-34AS-0000, I-TCB-05KX-00AS-0000, I-TCB-05NK-10AS-0000, I-RLW-05AX-34AS-0000, I-RLW-05BX-34AS-0000, I-RLW-06AX-34AS-0000, I-RLW-06BX-34AS-0000, I-RLW-05BL-40V3-0000, I-RLW-05BL-40V4-0000, I-RLW-05BL-40V5-0000, I-RLW-05BL-40V6-0000, I-RLW-05BB-63AS-0000, I-RLW-05BB-MXAS-0000, I-RLW-03AX-34AS-0000, I-RLW-03BX-34AS-0000, I-TCB-03JA-10AS-0020, I-TCB-05JA-10AS-0020, I-TCB-03JB-10AS-0020, I-TCB-05JB-10AS-0020, I-MCB-05NA-10AS-0000, I-MCB-05NB-10AS-0000, I-MCB-10DC-08AS-0042, I-RLW-03AW-29AS-0000, I-RLW-06BD-MXAS-0000, I-RLW-05AM-29AS-0000, I-RLW-05BM-29AS-0000, I-RLW-05AD-51LA-0000, I-RLW-06AF-MXAS-0000, I-RLW-03BF-35AS-0000, I-RLW-03AF-35AS-0000, I-RLW-05BW-MXAS-0000, I-RLW-05AR-29AS-0000, I-RLW-05BR-29AS-0000, I-RLW-05AR-51AS-0000, I-RLW-05BC-40AS-0000, I-RLW-10AC-24AS-0000, I-RLW-10AC-40AS-0000, I-RLW-10BC-24AS-0000, I-RLW-05BC-40VX-0000, I-LDW-3560-001, I-CB-71540R, I-CB-81320R, I-CB-81355, I-CB-81540R, I-RLW-05BL-24V5-0000, I-RLW-05BL-24V6-0000, I-RLW-05BM-29V2-0000, I-RLW-05BM-29V3-0000, I-RLW-05AW-51AS-0000, I-RLW-05AW-MXAS-0000, I-RLW-05BW-29AS-0000, I-RLW-05BW-51AS-0000, I-RLW-05AL-40V6-0000, I-RLW-05BL-24V2-0000, I-RLW-05BL-24V3-0000, I-RLW-05BL-24V4-0000, I-TCB-03NA-10AS-0010, I-TCB-05NA-10AS-0000, I-TCB-05NB-10AS-0000, I-TCB-05NB-25AS-0000, I-RLW-05AM-29V3-0000, I-RLW-05AM-29V4-0000, I-RLW-05AM-29V5-0000, I-RLW-05AM-29V6-0000, Irrigation Pump PP-01 Reusable Blade B3R, Disposable Blade B3D Image Processor VLM-02, VLM-03, HUV-02, MS-8; Single-use Rhinolaryngoscope RH-M58, RH-M52, RH-M50, RH-M40, RH-M32, RH-M22, RH-M58H, RH-M52H, RH-M40H, RH-M32A; SpO2 Pulse Oximeter Sensor (Reusable) A1418-SA203MV, A1418-SA203MU Video Laryngoscope, VL3H (N2865 / N3965 / N5065 / H5055 / H5065 / H5075) Video Laryngoscope, VL3S (M28 / M39 / M52 / M58/ M30/ M40/M28-1/ M39-1/ M40-1/ M52-1/ M58-1) Video Laryngoscope, VLMCF

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2023-04-12
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2025-11-24
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2026-04-17
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-07-14
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2016-06-15
FFL Dislodger, Stone, Basket, Ureteral, Metal Gastroenterology, Urology Class 2 876.4680 2026-05-19
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2025-02-04
FBN Choledochoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-02-04
NTN Led Light Source Gastroenterology, Urology Class 2 876.1500 2025-02-04
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-02-04
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2023-11-20
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-03-11
FBN Choledochoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-03-11
FEM Accessories, Photographic, For Endoscope (Exclude Light Sources) Gastroenterology, Urology Class 1 876.1500 2021-07-30
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2025-11-24
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2026-04-17
FQH Lavage, Jet General Hospital Class 2 880.5475 2025-12-25
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2016-06-15
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2024-05-06
DQA Oximeter Cardiovascular Class 2 870.2700 2026-04-17
CAL Laryngoscope, Non-Rigid Anesthesiology Class 1 868.5530 2018-12-23

Official Correspondent

Cathy Shi

US Agent Details

Dennis Xu Business: Performance International, Inc. Email: ybx99@yahoo.com Phone: (919) 8590478

Related Public Records

Same Entity

Shenzhen HugeMed Medical Technical Development 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
K811059 Pentax Precision Instrument Corp. PENTAX BRONCHOFIBERSCOPE #FB-15A 1981-05-27
K142934 Covidien CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved 2015-06-17
K240075 FUJIFILM Healthcare Americas Corporation FUJIFILM Endoscope Model EB-710XT 2024-02-07
K880323 Medtronic Vascular MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR 1988-03-22
K230752 FUJIFILM Healthcare Americas Corporation Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) 2023-09-15

Related Recall Records

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Z-0025-2020 AURIS HEALTH INC 2
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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-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012797688. Last updated year: 2026. Please use registration number 3012797688 when referencing this establishment in official correspondence.
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