Guilin Refine Medical Instrument Co., Ltd.

Manufacturer and brand owner in Guilin, Guangxi, China. 7 device types, 6 products catalogued, 3 clearances.

Registry build 21.09.26

Guilin Refine Medical Instrument Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Pick, Massaging, Scaler, Ultrasonic and 5 other device types. 6 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.

7device types registered with the FDA
6products catalogued under its own name
3510(k) clearances

Registration

FDA registration record for Guilin Refine Medical Instrument Co., Ltd.
Registered name GUILIN REFINE MEDICAL INSTRUMENT CO., LTD.
Status Registered
Registration expires 2026
Registration number 3016075921
FEI number 3016075921
DUNS 407578472
Establishment type Contract manufacturer, Manufacturer, Exporter

Chinese Registration

Chinese company register details for Guilin Refine Medical Instrument Co., Ltd.
Chinese legal name 桂林市锐锋医疗器械有限公司
Unified social credit code 91450300MA5L5UXK83
Source NMPA UDI database

Location

Address of Guilin Refine Medical Instrument Co., Ltd.
City Guilin
Province Guangxi
Address NO.8-3, Information Industrial Park, High-Tech Zone, Qixing District
Postal code 541004
Country China

What It Makes

Device types Guilin Refine Medical Instrument Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Activator, Ultraviolet, For Polymerization Class 2 Curing Light (Model: MaxCure9) 2023 7
Agent, Polishing, Abrasive, Oral Cavity Class 1 Dental Prophylaxis Powder, Model: PT-X1, PT-X2, PT-X3, PT-X6, PT-X5, PT-X7 2022 25
Pick, Massaging Class 1 Ultrasonic Activator (Model: VAT-3) 2023 46
Plugger, Root Canal, Endodontic Class 1 Gutta Percha Obturation System, MaxFill-G, MaxFill-P 2022 19
Scaler, Ultrasonic Class 2 2024 14
Unit, Suction Operatory Class 1 External Oral Aerosol Suction System 2020 23
Unit, X-Ray, Extraoral With Timer Class 2 Portable Dental X-ray Device (Model: GT-1) 2026 8

Own-Brand Listings

Devices catalogued by Guilin Refine Medical Instrument Co., Ltd.
Product Code Catalogue numbers
Refine ELC 10
Refine EBZ 9
Refine EJR 6
Refine EKR 2
Refine HOY 1
Refine JET 1

Clearances

510(k) clearances naming Guilin Refine Medical Instrument Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K254018 2026-02-19 EHD Traditional This company
K230641 2023-11-21 ELC Traditional This company
K223414 2023-11-15 EBZ Traditional This company

From the Company

Published by the company on its own website, not by the FDA.

Information published by Guilin Refine Medical Instrument Co., Ltd.
Main products Ultrasonic scalers, Ultrasonic surgical systems, Curing lights, X-ray equipment, Endodontic devices
Certifications CE, PDA, ISO13485
Export markets 105+ countries
OEM and ODM Offered

Nearby Manufacturers

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer