Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016045249

FEI Number

3016045249

Entity Name

HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.

City/State/Country

Xiangtan Hunan, CN

Establishment Address

1/F, Building 12, Innovation and Entrepreneurship Service Center, No.9 Chuanqi West road, Jiuhua Economic Development Zone,, Xiangtan Hunan 411100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hunan Vathin Medical Instrument Co., Ltd. (Owner Number: 10062555)

Owner / Operator Contact Address

Pittsfield, Massachusetts, Pittsfield, MA 01201, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vathin@ H-SteriScopeTM I Single-use flexible Video Bronchoscope, BCV1-K1, BCV1-K2, BCV1-M1, BCV1-M2, BCV1-O1, BCV1-O2 Vathin@ Digital Video Processor, DVP-A1 Vathin@ H-SteriScopeTM I Single-use flexible Video Bronchoscope, BCV1-01, BCV1-02, BCV1-C1, BCV1-C2, BCV1-H1, BCV1-H2 Vathin®Digital Video Monitor, DVM-A1, DVM-A2 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, BCV1-0M1, BCV1-0M2, BCV1-KS3-L Single-use Ureteral Access Sheath Single-use Flexible Ureteroscope, US-S2600, US-E2600, US-S2600R, US-E2600R Digital Video Monitor, DVM-B1 Single-use flexible Bronchoscope Digital Video Monitor Single-use sampler Vathin@ HSteriScopeTM I Single-use flexible Video Bronchoscope, BCV1- S1, BCV1-S2, BCV1-U1, BCV1-U2, BCV1-W1, BCV1-W2 Vathin®Digital Video Monitor, DVM-B1, DVM-B2 Vathin@ Digital Video Processor, DVP-A1 Vathin@ HSteriScopeTM I Single-use flexible Video Bronchoscope, BCV1- 01, BCV1-02, BCV1-C1, BCV1-C2, BCV1-H1, BCV1-H2 Vathin@ HSteriScopeTM I Single-use flexible Video Bronchoscope, BCV1- K1, BCV1-K2, BCV1- M1, BCV1-M2, BCV1- O1, BCV1-O2 Vathin@ HSteriScopeTM I Single-use flexible Video Bronchoscope, BCV1- 0M1, BCV1-0M2, BCV1-KS3-L Vathin®Digital Video Monitor, DVM-A1, DVM-A2 Single-Use Ureteral Access Sheath Single-Use Flexible Rhinolaryngoscope Digital Video Processor Digital Video Monitor Single-use Flexible Cystoscope Vathin® Video Bronchoscope System Single-use Flexible Ureteroscope Vathin® Single-use Flexible Ureteroscope, US-S170, US-E170, US-S180, US-E180 Vathin® Single-use Flexible Ureteroscope, US-S170R, US-E170R Vathin@ Digital Video Processor, DVP-A1 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-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, BCV1-01, BCV1-02, BCV1-C1, BCV1-C2, BCV1-H1, BCV1-H2 Trolley with pylon , MET-A2 Trolley,MET-A1,MC-A1 Pylon , ST-A1,MP-A1,MP-A2,MP-A3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2022-03-09
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-07-29
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-10-27
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-02-06
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-05-16
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-10-27
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2022-12-17
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-02-06
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-12-24
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-12-30
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-05-08
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-05-24
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2020-02-18
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2023-10-30

Official Correspondent

Lina Fei

US Agent Details

Thomas Tang Email: usagency@126.com Phone: (631) 7511103

Related Public Records

Same Entity

Hunan Vathin Medical Instrument Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016045249. Last updated year: 2026. Please use registration number 3016045249 when referencing this establishment in official correspondence.