Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030504644

FEI Number

3030504644

Entity Name

HUNAN ENDOSO LIFE TECHNOLOGY CO., LTD

City/State/Country

XiangTan Hunan, CN

Establishment Address

4th floor, Building 10, Innovation and Entrepreneurship Center, No. 31, Dongfeng Road, Heping Street, XiangTan Hunan 411100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hunan Endoso Life Technology Co., Ltd (Owner Number: 10089503)

Owner / Operator Contact Address

4th floor, Building 10, Innovation and Entrepreneurship Center, No. 31, Dongfeng Road, Heping Street, Xiangtan, CN-HN 411100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Single-use Bronchoscope, BC12-1, BC12-2, BC20-1, BC20-2, BC22-1, BC22-2, BC22-3, BC28-1, BC28-2, BC28-3 Endoscopic Image Processor, P1-A, P1-B, P1-C, P1-D, P1-E, P2-A, P2-B, P2-C, P2-D, P2-E Laparoscope, 4KA0, 4KA30, 4KA45, 4KA0R, 4KA30R, 4KA45R Single-Use Digital Flexible Ureteroscope, PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12 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 Endoscopic Light Source, HL2000-L1, HL2000-L1-N Endoscopic Light Source, HL5000-L1, HL5000-L1-N Urologic Guidewire, YS-HZ25-150, YS-HZ28-150, YS-HZ32-150, YS-HZ35-150 Urologic Guidewire, YS-BZ25-150, YS-BZ28-150, YS-BZ32-150, YS-BZ35-150 Urologic Guidewire, YS-NZ25-150, YS-NZ28-150, YS-NZ32-150, YS-NZ35-150 Urologic Guidewire, YS-NW25-150, YS-NW28-150, YS-NW32-150, YS-NW35-150 Urologic Guidewire, YS-BW25-150, YS-BW28-150, YS-BW32-150, YS-BW35-150 Urologic Guidewire, YS-HW25-150, YS-HW28-150, YS-HW32-150, YS-HW35-150 Endoscopic Image System, U400, U400-A, U400-B, U400-C, U400-D 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

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	2024-02-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-12-13
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-02-05
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2025-02-05
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2025-02-13
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-02-05
FWF	Camera, Television, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2025-02-13

Official Correspondent

Fu Wang

US Agent Details

Andy Smith Business: GRZAN GROUP INC. Email: info@grzan-ar.com Phone: (332) 2015192

Related Public Records

Same Entity

Hunan Endoso Life Technology 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
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22

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
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030504644. Last updated year: 2026. Please use registration number 3030504644 when referencing this establishment in official correspondence.