Shenzhen Hugemed Medical Technical Development Co., Ltd
Shenzhen Guangdong, CN
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Shenzhen Hugemed Medical Technical Development Co., Ltd between 2023 and 2026. The busiest year on record is 2024, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 2 |
| 2024 | 3 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260892 | Suction Pump (SU-90) | BTA | Substantially Equivalent | |
| K250695 | Single-use Ureteral Access Sheath | FED | Substantially Equivalent | |
| K241444 | Biliary Pancreaticobiliary Scope System | FBN | Substantially Equivalent | |
| K240374 | Ureterorenoscope System | FGB | Substantially Equivalent | |
| K232435 | Rhinolaryngoscope system | EOB | Substantially Equivalent | |
| K231497 | Choledochoscope System | FBN | Substantially Equivalent | |
| K231118 | Cystoscope System | FAJ | Substantially Equivalent | |
| K222910 | Bronchoscope System | EOQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012797688 | 3012797688 | SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD | 401, 501, Building 4, Haizhi Technology Park, Fortis, No. 17, Bulan Road,, Shenzhen Guangdong 518112 CN | 2026 | and 13 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)
- KDQBottle, Collection, Vacuum
- EOQBronchoscope (Flexible Or Rigid)
- IKDCable, Electrode
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- KQMCamera, Surgical And Accessories
- FBNCholedochoscope And Accessories, Flexible/Rigid
- FMHContainer, Specimen, Sterile
- FAJCystoscope And Accessories, Flexible/Rigid
- FFLDislodger, Stone, Basket, Ureteral, Metal
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- LRCInstrument, Ent Manual Surgical
- CALLaryngoscope, Non-Rigid
- CCWLaryngoscope, Rigid
- FQHLavage, Jet
- NTNLed Light Source
- EOBNasopharyngoscope (Flexible Or Rigid)
- DQAOximeter
- BTAPump, Portable, Aspiration (Manual Or Powered)
- FGBUreteroscope And Accessories, Flexible/Rigid
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain