Sanbor Medical

FDA Filings

This page includes the latest FDA filings for Sanbor Medical. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Sanbor Medical holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Sanbor Medical Xiamen, Inc.
• Wayne Meng

FDA Registration(s)

• Registration Number: 3007583504
• FEI Number: 3007583504
• Name: Sanbor Medical Xiamen, Inc.
• Owner & Operator: Sanbor Medical
• Contact Address: 5050 Tilghman Street Suite 410; Allentown PA 18104 US
• Official Correspondent:
  • Wayne Meng
  • x-610-5308500-x
• US Agent:
  • Wayne Meng
  • SANBOR MEDICAL
  • 484 6642678
  • wmeng@pmd-healthcare.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1776 Lv Ling Road ; Xiamen Fujian, 361009 CN
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device

• Registration Number: 3015539988
• FEI Number: 3015539988
• Name: Wayne Meng
• Owner & Operator: Sanbor Medical
• Contact Address: 5050 Tilghman Street Suite 410; Allentown PA 18104 US
• Official Correspondent:
  • Wayne Meng
  • x-610-5308500-x
• US Agent:
  • Wayne Meng
  • SANBOR MEDICAL
  • 484 6642678
  • wmeng@pmd-healthcare.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5050 Tilghman Street Suite 410; Allentown, PA 18104 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3007113169
• FEI Number: 3007113169
• Name: Sanbor Medical
• Owner & Operator: Sanbor Medical
• Contact Address: 5050 Tilghman Street Suite 410; Allentown PA 18104 US
• Official Correspondent:
  • Wayne Meng
  • x-610-5308500-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 5050 Tilgham Street Suite 410; Allentown, PA 18104 US

FDA Filings

Device Company	Device	Date
PMN K124045 | JDR Sanbor Medical Xiamen, Inc. [Sanbor Medical]	Wright Medical Staple	2019-11-20
PMN K190970 | HWC Sanbor Medical Xiamen, Inc. [Sanbor Medical]	Taylor Bunion	2019-11-18
PMN K081939 | GEX Sanbor Medical Xiamen, Inc. [Sanbor Medical]	OmniGuide BeamPath? Fiber Optic HandPiece System	2019-11-14
LXH Sanbor Medical Xiamen, Inc. [Sanbor Medical]	Radial Head	2019-10-29
HWT Sanbor Medical Xiamen, Inc. [Sanbor Medical]	Radial Head	2019-10-24
PMN K003126 | GEI Sanbor Medical Xiamen, Inc. [Sanbor Medical]	Bipolar Needle	2019-08-16
PMN K160014 | DXN Sanbor Medical Xiamen, Inc. [Sanbor Medical]	PMD Blood Pressure Monitor	2018-05-07
PMN K141362 | DQA Sanbor Medical Xiamen, Inc. [Sanbor Medical]	PMD Pulse Oximeter	2018-05-07
FRI Sanbor Medical Xiamen, Inc. [Sanbor Medical]	PMD Weight Scale	2018-05-07
PMN K103575 | BZG Wayne Meng [Sanbor Medical]	Spiro PD Personal Spirometer	2016-02-22
PMN K103575 | BZG Sanbor Medical Xiamen, Inc. [Sanbor Medical]	Spiro PD Personal Spirometer	2016-02-22
EIF Sanbor Medical	Paraband Dental	2010-06-24
EIF Sanbor Medical Xiamen, Inc. [Sanbor Medical]	Paraband Dental	2010-06-24
PMN K882017 | BSY Sanbor Medical Xiamen, Inc. [Sanbor Medical]	Suction Easy	2009-05-27

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020080858336	Xiamen,China (Mainland) -> Los Angeles, California	LEADWIRES	12 CTN
2019120944100	Xiamen,China (Mainland) -> Los Angeles, California	SUCTION EZ	50 CTN
2019103112737	Xiamen,China (Mainland) -> New York/Newark Area, Newark, New Jersey	BIPOLAR NEEDLE	38 CTN