FDA Registration
Active
🇨🇳 China
Sanbor Medical Xiamen, Inc.
Reg #: 3007583504
·
FEI: 3007583504
·
Expires 2026
Products
16
Proprietary Names
15
Establishment Types
2
Classifications
16
Registration Details
- Registration Name
- Sanbor Medical Xiamen, Inc.
- Registration Number
- 3007583504
- FEI Number
- 3007583504
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1776 Lv Ling Road
- City
- Xiamen Fujian
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K141362
Owner / Operator
- Firm Name
- Sanbor Medical
- Operator Number
- 10028522
- Address
- 7584 Morris Court, Suite 218
- City
- Allentown
- State
- PA
- Postal Code
- 18106
- Country
- US
- Correspondent
- Wayne Meng
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-10-29 |
| System And Accessories, Isolated Heart, Transport And Preservation | MSB | Class 2 | Gastroenterology, Urology | No | 2025-09-26 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2009-05-27 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2018-10-26 |
| Template | HWT | Class 1 | Orthopedic | No | 2019-10-24 |
| System, Perfusion, Kidney | KDN | Class 2 | Gastroenterology, Urology | No | 2025-09-26 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2019-08-16 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-11-18 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2018-05-07 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2021-01-20 |
| Scale, Stand-On, Patient | FRI | Class 1 | General Hospital | No | 2018-05-07 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2018-05-07 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2010-06-24 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2019-11-14 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2016-02-22 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2024-07-24 |
Proprietary Names
Radial Head
SherpaPak CTS
Suction Easy
PancreasPak
Bipolar Needle
Taylor Bunion
PMD Pulse Oximeter
Lag Screw sizer
Wright Medical Staple
PMD Weight Scale
PMD Blood Pressure Monitor
Paraband Dental
OmniGuide BeamPath® Fiber Optic HandPiece System
Spiro PD Personal Spirometer
SherpaPak LUNGguard
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device