Data / Medical devices / China / Sanbor Medical Xiamen, Inc.

Sanbor Medical Xiamen, Inc.: FDA-registered device maker in Xiamen Fujian, China, 2 510(k) clearances

Name: Sanbor Medical Xiamen, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sanbor Medical Xiamen, Inc. is registered with the FDA (registration 3007583504) in Xiamen Fujian, China. It lists 16 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 2, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007583504
Address: 1776 Lv Ling Road, Xiamen Fujian, China, 361009
Owner or operator: Sanbor Medical (10028522)
Roles: Contract manufacturer, Repackager or relabeler
First device listed: May 27, 2009
Registered through: 2026
Brand names listed: Bipolar Needle, Lag Screw sizer, OmniGuide BeamPath® Fiber Optic HandPiece System, PMD Blood Pressure Monitor, PMD Pulse Oximeter, PMD Weight Scale, PancreasPak, Paraband Dental and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Retractor, Dental	EIF	1	Contract manufacturer	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Contract manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Contract manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Contract manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Repackager or relabeler	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Contract manufacturer	accessdata.fda.gov
Scale, Stand-On, Patient	FRI	1	Repackager or relabeler	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Contract manufacturer	accessdata.fda.gov
Spirometer, Diagnostic	BZG	2	Contract manufacturer	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Contract manufacturer	accessdata.fda.gov
System And Accessories, Isolated Heart, Transport And Preservation	MSB	2	Contract manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Repackager or relabeler	accessdata.fda.gov
System, Perfusion, Kidney	KDN	2	Contract manufacturer	accessdata.fda.gov
Template	HWT	1	Contract manufacturer	accessdata.fda.gov
Ventilatory Effort Recorder	MNR	2	Contract 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
February 2, 2016	K160014	iHealth Track Blood Pressure Monitor	DXN	Substantially Equivalent	Andon Health Co, Ltd.	accessdata.fda.gov
April 23, 2015	K141362	PULSE OXIMETER CMS50EW	DQA	Substantially Equivalent	Contec Medical Systems Co.,Ltd	accessdata.fda.gov

Compare with other makers

Updated February 2, 2016. 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.