Hunan Vathin Medical Instrument Co., Ltd.
Manufacturer and brand owner in Xiangtan, Hunan, China. 6 device types, 13 products catalogued, 17 clearances.
Hunan Vathin Medical Instrument Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Bronchoscope (Flexible Or Rigid), Nasopharyngoscope (Flexible Or Rigid) and 4 other device types. 13 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
6device types registered with the FDA
13products catalogued under its own name
17510(k) clearances
Registration
| Registered name | HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016045249 |
| FEI number | 3016045249 |
| DUNS | 554484862 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 湖南省华芯医疗器械有限公司 |
|---|---|
| Unified social credit code | 91430300MA4PQYCX8Y |
| Source | NMPA UDI database |
Location
| City | Xiangtan |
|---|---|
| Province | Hunan |
| Address | 1/F, Building 12, Innovation and Entrepreneurship Service Center, No.9 Chuanqi West road |
| Postal code | 411100 |
| 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 | Trolley,MET-A1,MC-A1, Trolley with pylon , MET-A2, Pylon , ST-A1,MP-A1,MP-A2,MP-A3 | 2023 | 8 |
| Bronchoscope (Flexible Or Rigid) | Class 2 | Vathin® Video Bronchoscope System, Vathin@ Digital Video Processor, DVP-A1, Vathin@ H-SteriScopeTM I Single-use flexible Video Bronchoscope, BCV1-S1, BCV1-S2, BCV1-U1, BCV1-U2, BCV1-W1, BCV1-W2, Vathin@ H-SteriScopeTM I Single-use flexible Video Bronchoscope, BCV1-K1, BCV1-K2, BCV1-M1, BCV1-M2, BCV1-O1, BCV1-O2, Vathin@ H-SteriScopeTM I Single-use flexible Video Bronchoscope, BCV1-0M1, BCV1-0M2, BCV1-KS3-L, Vathin@ H-SteriScopeTM I Single-use flexible Video Bronchoscope, BCV1-01, BCV1-02, BCV1-C1, BCV1-C2, BCV1-H1, BCV1-H2 and 10 more | 2020 | 21 |
| Cystoscope And Accessories, Flexible/Rigid | Class 2 | Vathin® Single-use Flexible Cystoscope, CY-S1B01, CY-S1D01, CY-S1E01, CY-S1H01, CY-S1J01, Vathin® Single-use Flexible Cystoscope, CY-S1B00, CY-S1D00, CY-S1E00, CY-S1H00, CY-S1J00, Vathin® Single-use Flexible Cystoscope, CY-S1B00R, CY-S1D00R, CY-S1E00R, CY-S1H00R, CY-S1J00R, Vathin® Single-use Flexible Cystoscope, CY-S1B01R, CY-S1D01R, CY-S1E01R, CY-S1H01R, CY-S1J01R, Digital Video Monitor, Single-use Flexible Cystoscope | 2022 | 16 |
| Endoscopic Access Overtube, Gastroenterology-Urology | Class 2 | Single-use Ureteral Access Sheath | 2024 | 19 |
| Nasopharyngoscope (Flexible Or Rigid) | Class 2 | Vathin® Video Rhinolaryngoscope System, Single-Use Flexible Rhinolaryngoscope | 2022 | 7 |
| Ureteroscope And Accessories, Flexible/Rigid | Class 2 | Digital Video Processor, Vathin® Single-use Flexible Ureteroscope, US-S170, US-E170, US-S180, US-E180, Vathin® Single-use Flexible Ureteroscope, US-S170R, US-E170R, Single-use Flexible Ureteroscope, Single-use Flexible Ureteroscope, US-S2600, US-E2600, US-S2600R, US-E2600R, Digital Video Monitor, DVM-B1 | 2023 | 21 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Single-Use Flexible Cystoscope | FAJ | 28 |
| Single-Use flexible Video Bronchoscope | EOQ | 27 |
| Single-use Ureteral Access Sheath | FED | 20 |
| Single-use Flexible Bronchoscope | EOQ | 15 |
| Single-use Flexible Ureteroscope | FGB | 14 |
| Single-Use Flexible Rhinolaryngoscope | EOB | 8 |
| Digital Video Monitor | EOQ | 6 |
| Single-use sampler | EOQ | 3 |
| Digital Video Processor | EOQ | 2 |
| Trolley with pylon | FEM | 1 |
| Digital Video Processor | FGB | 1 |
| Trolley | FEM | 1 |
| Pylon | FEM | 1 |
Clearances
17 clearances name Hunan Vathin Medical Instrument Co., Ltd. as applicant. 1 is 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 |
|---|---|---|---|---|
| K250232 | 2025-07-25 | EOQ | Traditional | This company |
| K251599 | 2025-07-03 | FED | Special | This company |
| K250785 | 2025-05-06 | FGB | Traditional | This company |
| K243117 | 2025-01-29 | FGB | Traditional | This company |
| K242416 | 2025-01-16 | EOQ | Traditional | This company |
| K242535 | 2024-12-18 | FAJ | Traditional | This company |
| K241612 | 2024-10-29 | EOQ | Traditional | This company |
| K240167 | 2024-10-08 | FED | Traditional | This company |
| K241434 | 2024-10-04 | FGB | Special | This company |
| K231135 | 2024-01-17 | FGB | Traditional | This company |
| K230536 | 2023-06-14 | EOB | Traditional | This company |
| K230200 | 2023-05-18 | FGB | Traditional | This company |
| K223836 | 2023-05-15 | EOQ | Traditional | This company |
| K221581 | 2022-11-18 | EOB | Traditional | This company |
| K221580 | 2022-11-18 | FAJ | Traditional | This company |
| K213635 | 2022-02-28 | EOQ | Traditional | This company |
| K191828 | 2020-02-13 | EOQ | Traditional | This company |
| K202346 | 2021-02-19 | EOQ | Traditional | Veran Medical Technologies, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2018 |
|---|---|
| Employees | 15-50 |
| Factory area | 3,500 m² |
| Main products | Disposable endoscopes, Bronchoscopes |
| Certifications | FDA, CE, ISO13485 |
| Export markets | International markets |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Hunan Endoso Life Technology Co., Ltd. | 7 |
| 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.