Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008797804

FEI Number

3008797804

Entity Name

ALTON SHANGHAI MEDICAL INSTRUMENTS CO LTD

City/State/Country

Shanghai, CN

Establishment Address

No.24 Building Jinshao Rd.1688.Baoshan District, Shanghai 200949, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ALTON shanghai medical Instruments Co Ltd (Owner Number: 10034985)

Owner / Operator Contact Address

No.24 Building, Jinshao Rd.1688, Baoshan District., Shanghai, CN-SH 200949, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bite Blocks Disposable Cytology Brush (AF series) Disposable hemorrhoid ligation Ligation device Disposable Drainage Collection device Disposable Injection Needle Biliary Plastic Stent Multi-Band Ligator Disposable measuring Ruler Disposable Cleaning Brush Port Hole Cleaning Brush Reusable Cleaning Brush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-12-09
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-12-09
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2011-01-23
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2025-12-09
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2025-12-09
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2023-03-22
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2022-07-10
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2025-12-09
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-12-05
PTT	Biliary Catheter For Irrigation And Contrast Injection, Exempt	Gastroenterology, Urology	Class 2	876.5010	2026-06-05
MND	Ligator, Esophageal	Gastroenterology, Urology	Class 2	876.4400	2023-03-22
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2025-12-09
FDY	Device, Measuring, For Panendoscope	Gastroenterology, Urology	Class 1	876.1500	2026-06-05
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2011-01-23

Official Correspondent

Haoxiang HE

US Agent Details

Brian Karler Brian Karler Business: XENTURA MEDICAL, INC. Email: brian@xentura.com Phone: (480) 7976714

Related Public Records

Same Entity

ALTON shanghai medical Instruments 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
K232314	FUJIFILM Healthcare Americas Corporation	Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)	2023-09-01
K000397	Boston Scientific Corp	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL	2000-03-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2023	Hobbs Medical, Inc.	2	Hobbs Medical Cytology Brush Catalog Number: 4204
Z-0014-2023	Hobbs Medical, Inc.	2	Hobbs Medical Cytology Brush Catalog Number: 4206
Z-0037-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001
Z-0038-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004
Z-0039-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023

Similar Registrations

Registration Number	Establishment Name	Location
3006161756	FUJIFILM Healthcare Manufacturing Corporation Sano Office	Sano City Tochigi, JP
3004837686	Micro-Tech (Nanjing) Co., Ltd.	NAN JING Jiangsu, CN
2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	Auburn, MA, US
3015136743	STERI-TECH CO.,LTD.	KAZO-SHI Saitama, JP
8010047	OLYMPUS MEDICAL SYSTEMS CORP.	HACHIOJI-SHI Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008797804. Last updated year: 2026. Please use registration number 3008797804 when referencing this establishment in official correspondence.