FDA Registration
Active
🇨🇳 China
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD
Reg #: 3012797688
·
FEI: 3012797688
·
Expires 2026
Products
21
Proprietary Names
106
Establishment Types
2
Classifications
21
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Registration Details
- Registration Name
- SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD
- Registration Number
- 3012797688
- FEI Number
- 3012797688
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 401, 501, Building 4, Haizhi Technology Park, Fortis, No. 17, Bulan Road,, Xialilang Community, Nanwan Street, Longgang District,
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222910
Owner / Operator
- Firm Name
- Shenzhen HugeMed Medical Technical Development Co., Ltd
- Operator Number
- 10052108
- Address
- 401, 501, Building 4, Haizhi Technology Park, Fortis, No.17, Bulan Road,, Xialilang Community, Nanwan Street, Longgang District,
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518112
- Country
- CN
- Correspondent
- Cathy Shi
US Agent
- Business Name
- Performance International, Inc.
- Contact Name
- Dennis Xu
- Address
- 4004 Pepperton Dr.
- City
- Raleigh
- State
- NC
- ZIP
- 27606
- Country
- US
- [email protected]
- Phone
- 919 8590478
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2023-04-12 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2025-11-24 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2026-04-17 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2025-07-14 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2016-06-15 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2026-05-19 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2025-02-04 |
| Choledochoscope And Accessories, Flexible/Rigid | FBN | Class 2 | Gastroenterology, Urology | No | 2025-02-04 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2025-02-04 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2025-02-04 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2023-11-20 |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | Class 1 | Gastroenterology, Urology | No | 2021-07-30 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2025-11-24 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2026-04-17 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2025-12-25 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2016-06-15 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2024-05-06 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2026-04-17 |
| Laryngoscope, Non-Rigid | CAL | Class 1 | Anesthesiology | No | 2018-12-23 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2026-05-19 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2024-05-13 |
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
Suction Pump SU-90
Single-use Ureterorenoscope HU30S, HU30M, HU30; Image Processor HUV-01, HUV-02, MS-8, VLM-03
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device