Shenzhen Hugemed Medical Technical Development Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 22 device types, 15 products catalogued, 8 clearances.
Shenzhen Hugemed Medical Technical Development Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Lavage, Jet and 20 other device types. 15 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
22device types registered with the FDA
15products catalogued under its own name
8510(k) clearances
Registration
| Registered name | SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012797688 |
| FEI number | 3012797688 |
| DUNS | 403655303 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳市宏济医疗技术开发有限公司 |
|---|---|
| Unified social credit code | 914403003059314716 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 401, 501, Building 4, Haizhi Technology Park, Fortis, No. 17, Bulan Road, |
| Postal code | 518112 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | Class 1 | Medical Display,HM -01, HMT-01 | 2021 | 8 |
| Bottle, Collection, Vacuum | Class 2 | Stone Collector 140mL-S, 180mL-L | 2025 | 88 |
| Bronchoscope (Flexible Or Rigid) | Class 2 | Image Processor VLM-02, VLM-03, MS-8, HUV-02, 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; | 2023 | 21 |
| Cable, Electrode | Class 2 | I-TCB-05ND-10AS-0000, I-TCB-05ND-20AS-0000, I-CBT-10NR-10CM-0001, I-TCB-10DN-08AS-0030,, I-RLW-10BN-MXAS-0001, I-RLW-10CN-MXAS-0001, I-RLW-04CN-29AS-0001, I-LDW-3552-001,, I-MCB-05NA-10AS-0000, I-MCB-05NB-10AS-0000, I-MCB-10DC-08AS-0042, I-RLW-03AW-29AS-0000,, I-RLW-05AD-51LL-0000, I-RLW-05AD-51RA-0000, I-RLW-05AD-51RL-0000, I-RLW-05AD-51VX-0000,, I-RLW-06AF-MXAS-0000, I-RLW-03BF-35AS-0000, I-RLW-03AF-35AS-0000,, I-RLW-05BL-40V3-0000, I-RLW-05BL-40V4-0000, I-RLW-05BL-40V5-0000, I-RLW-05BL-40V6-0000, and 49 more | 2026 | 47 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | Class 2 | I-DLP-05BM-40AM-0100, I-DLP-03AF-36AN-0100, I-DLP-03AF-36AN-0100,, I-DLP-03AC-40AT-0100, I-DLP-03AC-40AT-0100, I-DLP-03BC-40AT-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-05AM-40AM-0100, I-DLP-05AM-40AM-0100, I-DLP-05BM-40AM-0100,, I-DLP-05BU-40AS-0100, I-DLP-03AB-40AS-0100, I-DLP-03AB-40AS-0100, and 15 more | 2026 | 22 |
| Camera, Surgical And Accessories | Class 1 | Single-use Biliary Pancreaticobiliary Scope CL-A, CL-B; Image Processor HUV-02 | 2025 | 22 |
| Choledochoscope And Accessories, Flexible/Rigid | Class 2 | Single-use Biliary Pancreaticobiliary Scope CL-A, CL-B; Image Processor HUV-02, Single-use Choledochoscope CH-M50, CH-M52, CH-M40, CH-M32, CH-M40H, CH-M52H,, Image Processor HUV-01, HUV-02, VLM-03, MS-8 | 2024 | 8 |
| Container, Specimen, Sterile | Class 1 | Broncho Sampler BS01 | 2025 | 79 |
| Cystoscope And Accessories, Flexible/Rigid | Class 2 | 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; | 2023 | 16 |
| Dislodger, Stone, Basket, Ureteral, Metal | Class 2 | StoneRetrix™ 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 | 2026 | 21 |
| Endoscopic Access Overtube, Gastroenterology-Urology | Class 2 | 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,, Y-12-45, Y-12-50, Y-12-55, 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, | 2025 | 19 |
| Endoscopic Guidewire, Gastroenterology-Urology | Class 2 | Routix™ Disposable Urologic Guidewire UG-3215-STA, UG-3515-STA, UG-3515-BEA, UG-3515-STB | 2026 | 21 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Class 2 | Single-use Biliary Pancreaticobiliary Scope CL-A, CL-B; Image Processor HUV-02, Single-use Choledochoscope CH-M50, CH-M52, CH-M40, CH-M32, CH-M40H, CH-M52H,, Image Processor HUV-01, HUV-02, VLM-03, MS-8 | 2024 | 8 |
| Instrument, Ent Manual Surgical | Class 1 | Reusable Blade B3R, Disposable Blade B3D | 2016 | 11 |
| Laryngoscope, Non-Rigid | Class 1 | 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 | 2018 | 12 |
| Laryngoscope, Rigid | Class 1 | VL3R / VL3D, VL3D plus, VL4R,VL4D, VLDM-01;VLDM-02;VLDM-03;VLDM-04;, Vlrm;vldm, VL3N, VL4N, VL4REX, VL4DEX, VL3REX, VL3DEX | 2016 | 44 |
| Lavage, Jet | Class 2 | Irrigation Pump PP-01 | 2025 | 17 |
| Led Light Source | Class 2 | Single-use Biliary Pancreaticobiliary Scope CL-A, CL-B; Image Processor HUV-02 | 2025 | 11 |
| Nasopharyngoscope (Flexible Or Rigid) | Class 2 | Single-use Rhinolaryngoscope RH-M58, RH-M52, RH-M50, RH-M40, RH-M32, RH-M22, RH-M58H, RH-M52H, RH-M40H, RH-M32A;, Image Processor VLM-02, VLM-03, HUV-02, MS-8; | 2024 | 7 |
| Oximeter | Class 2 | SpO2 Pulse Oximeter Sensor (Reusable) A1418-SA203MV, A1418-SA203MU | 2026 | 70 |
| Pump, Portable, Aspiration (Manual Or Powered) | Class 2 | Suction Pump SU-90 | 2026 | 14 |
| Ureteroscope And Accessories, Flexible/Rigid | Class 2 | Image Processor HUV-01, HUV-02, MS-8, VLM-03;, Single-use Ureterorenoscope HU30S, HU30M, HU30, HU30SC, HU30S-V, HU30M-V, HU30SC-V, HU20; | 2024 | 21 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Single-use Ureteral Access Sheath | FED | 25 |
| Single-use Bronchoscope | EOQ | 12 |
| Single-Use Rhinolaryngoscope | EOB | 10 |
| HueRex™ Disposable Stone Retrieval Basket | FFL | 8 |
| Single-Use Ureterorenoscope | FGB | 7 |
| Single-Use Cystoscope | FAJ | 6 |
| Single-Use Choledochoscope | FBN | 6 |
| Single-use Biliary Pancreaticobiliary Scope | FBN | 2 |
| Image Processor | EOQ | 2 |
| Stone Collector | KDQ | 2 |
| Image Processor | FAJ | 2 |
| Irrigation Pump | FQH | 1 |
| Suction Pump | BTA | 1 |
| Broncho Sampler | FMH | 1 |
| Image Processor | EOB | 1 |
Clearances
8 clearances name Shenzhen Hugemed Medical Technical Development Co., Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260892 | 2026-05-14 | BTA | Traditional | This company |
| K250695 | 2025-07-08 | FED | Traditional | This company |
| K241444 | 2025-01-21 | FBN | Traditional | This company |
| K240374 | 2024-05-10 | FGB | Traditional | This company |
| K232435 | 2024-04-26 | EOB | Traditional | This company |
| K231497 | 2024-03-06 | FBN | Traditional | This company |
| K231118 | 2023-11-13 | FAJ | Traditional | This company |
| K222910 | 2023-04-11 | EOQ | Traditional | This company |
| K170536 | 2017-04-24 | DSA | Traditional | APK Technology Co., Ltd. |
| K082846 | 2009-04-03 | DQA | Traditional | APK Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Employees | 800 |
| Factory area | 60000 m² |
| Main products | Video laryngoscopes, Single-use endoscopes, Reusable endoscopes, Medical image processors, Endoscope accessories |
| Certifications | NMPA, CE, FDA, MDSAP, National High-tech Enterprise, Specialized Little Giant Enterprise |
| Export markets | 100+ countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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