Data / Medical devices / China / Shanghai Lange Medtech Co., Ltd.

Shanghai Lange Medtech Co., Ltd.: FDA-registered device maker in Shanghai, China, 1 510(k) clearance

Name: Shanghai Lange Medtech Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shanghai Lange Medtech Co., Ltd. is registered with the FDA (registration 3035858921) in Shanghai, China. It lists 16 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 3, 2025. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Shanghai Lange Medtech Co., Ltd.

FDA registration number: 3035858921
Address: 1st floor, Building 22, 1500 Duhui Road, Minhang District, Shanghai, China, 201108
Owner or operator: Shanghai Lange Medtech Co., Ltd. (10092484)
Roles: Manufacturer
First device listed: January 14, 2025
Registered through: 2026
Brand names listed: Balloon Inflation Devices, S06-30, Bone Biopsy Devices, 3.5x150, 3.5x200, Bone Cement Application Kits, S02-10, S02-101, S12-20, S12-201, Bone Cement Filler Devices, S03-01, S03-02, S03-03, S03-04, Bone Chisel, 5x250, 5x250x35°, 5x250x35° ,5x250x20° ,5x250x38°, 5x310, 8x8x295, Bone drills, S04-30, S04-34, Dilator inner tubes, S08-01, S08-03, Dilator outer tubes, S10-01, S10-02, S10-03 and more

Devices it lists

Device	Product code	Class	Role	Source
Arthroscope	HRX	2	Manufacturer	accessdata.fda.gov
Bone Marrow Biopsy Tray	PXO	1	Manufacturer	accessdata.fda.gov
Dilator, Catheter	GCC	1	Manufacturer	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer	accessdata.fda.gov
Head, Surgical, Hammer	GFB	1	Manufacturer	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Manufacturer	accessdata.fda.gov
Injector, Vertebroplasty (Does Not Contain Cement)	OAR	1	Manufacturer	accessdata.fda.gov
Instrument, Cutting, Orthopedic	HTZ	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov
Spatula, Surgical, General & Plastic Surgery	GAF	1	Manufacturer	accessdata.fda.gov
Spinal Channeling Instrument, Vertebroplasty	OCJ	1	Manufacturer	accessdata.fda.gov
Stripper, Vein, Reusable	GAI	1	Manufacturer	accessdata.fda.gov
Tamp	HXG	1	Manufacturer	accessdata.fda.gov
Tray, Surgical	LRP	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 3, 2025	K252458	Kyphoplasty Balloon Dilatation Catheters	HRX	Substantially Equivalent	Shanghai Lange Medtech Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 3, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.