Hunan Endoso Life Technology Co., Ltd.
Manufacturer and brand owner in Xiangtan, Hunan, China. 7 device types, 3 products catalogued, 3 clearances.
Hunan Endoso Life Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Led Light Source, Bronchoscope (Flexible Or Rigid) and 5 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2023.
7device types registered with the FDA
3products catalogued under its own name
3510(k) clearances
Registration
| Registered name | HUNAN ENDOSO LIFE TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3030504644 |
| FEI number | 3030504644 |
| DUNS | 722930494 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 湖南英术生命科技有限公司 |
|---|---|
| Unified social credit code | 91430300MA4T13DG8R |
| Source | NMPA UDI database |
Location
| City | Xiangtan |
|---|---|
| Province | Hunan |
| Address | 4th floor, Building 10, Innovation and Entrepreneurship Center, No. 31, Dongfeng Road, Heping Street |
| Postal code | 411100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | Class 2 | Endoscopic Image Processor, P1-A, P1-B, P1-C, P1-D, P1-E, P2-A, P2-B, P2-C, P2-D, P2-E, Single-use Bronchoscope, BC12-1, BC12-2, BC20-1, BC20-2, BC22-1, BC22-2, BC22-3, BC28-1, BC28-2, BC28-3 | 2024 | 21 |
| Camera, Television, Endoscopic, Without Audio | Class 1 | Endoscopic Camera System, P2-H1, P2-H2, P2-H3, P2-H4, P2-I1, P2-I2, P2-I3, P2-I4, Endoscopic Camera System, P2-J1, P2-J2, P2-J3, P2-J4, P2-K1, P2-K2, P2-K3, P2-K4, Endoscopic Image System, U500, U500-A, U500-B, Endoscopic Camera System, P2-F1, P2-F2, P2-F3, P2-F4, P2-G1, P2-G2, P2-G3, P2-G4, Endoscopic Image System, U400, U400-A, U400-B, U400-C, U400-D | 2025 | 6 |
| Dislodger, Stone, Basket, Ureteral, Metal | Class 2 | Stone Retrieval Basket, YS-408-17, YS-408-19, YS-410-17, YS-410-19, Stone Retrieval Basket, YS-308-17, YS-308-19, YS-310-17, YS-310-19 | 2025 | 21 |
| Endoscopic Guidewire, Gastroenterology-Urology | Class 2 | Urologic Guidewire, YS-HZ25-150, YS-HZ28-150, YS-HZ32-150, YS-HZ35-150, Urologic Guidewire, YS-NZ25-150, YS-NZ28-150, YS-NZ32-150, YS-NZ35-150, Urologic Guidewire, YS-BZ25-150, YS-BZ28-150, YS-BZ32-150, YS-BZ35-150, Urologic Guidewire, YS-HW25-150, YS-HW28-150, YS-HW32-150, YS-HW35-150, Urologic Guidewire, YS-BW25-150, YS-BW28-150, YS-BW32-150, YS-BW35-150, Urologic Guidewire, YS-NW25-150, YS-NW28-150, YS-NW32-150, YS-NW35-150 | 2025 | 21 |
| Laparoscope, General & Plastic Surgery | Class 2 | Laparoscope, 4KA0, 4KA30, 4KA45, 4KA0R, 4KA30R, 4KA45R | 2023 | 46 |
| Led Light Source | Class 2 | Endoscopic Light Source, HL5000-L1, HL5000-L1-N, Endoscopic Light Source, HL2000-L1, HL2000-L1-N | 2025 | 11 |
| Ureteroscope And Accessories, Flexible/Rigid | Class 2 | Single-Use Digital Flexible Ureteroscope, PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12 | 2025 | 21 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K241956 | 2025-01-22 | FGB | Traditional | This company |
| K231107 | 2024-02-15 | EOQ | Traditional | This company |
| K231725 | 2023-10-16 | GCJ | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2020 |
|---|---|
| Factory area | 3000+ m² |
| Main products | Rigid tube endoscopy systems, Single-use digital endoscopes, Reusable digital endoscopes, Optical rigid endoscopes, Endoscopic accessories |
| Export markets | Netherlands (operations mentioned) |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Hunan Vathin Medical Instrument Co., Ltd. | 6 |
| Chilecom Medical Devices Co Ltd | 5 |
| Alps Xiangtan Prosthetic & Orthotic Co., Ltd. | 1 |
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.
The manufacturer named here can complete this record.