Wuxi EA Medical Instruments Technologies Limited

Manufacturer and brand owner in Wuxi, Jiangsu, China. 6 device types, 14 products catalogued, 2 clearances.

Registry build 21.09.26

Wuxi EA Medical Instruments Technologies Limited is a repacker / relabeller holding a current FDA establishment registration. The registration covers Dental Hygiene Kit, Aligner, Sequential and 4 other device types. 14 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2019.

6device types registered with the FDA
14products catalogued under its own name
2510(k) clearances

Registration

FDA registration record for Wuxi EA Medical Instruments Technologies Limited
Registered name WUXI EA MEDICAL INSTRUMENTS TECHNOLOGIES LIMITED
Status Registered
Registration expires 2026
Registration number 3013556527
FEI number 3013556527
DUNS 421315681
Establishment type Repacker / relabeller, Manufacturer, Exporter

Chinese Registration

Chinese company register details for Wuxi EA Medical Instruments Technologies Limited
Chinese legal name 无锡时代天使医疗器械科技有限公司
Unified social credit code 91320200550292909M
Source NMPA UDI database

Location

Address of Wuxi EA Medical Instruments Technologies Limited
City Wuxi
Province Jiangsu
Address 1F, building 1 and building 2, No. 1619, Huishan Avenue, Huishan Economic Development Zone
Postal code 214174
Country China

What It Makes

Device types Wuxi EA Medical Instruments Technologies Limited is registered to make
Device type Class Listed under the names Listed since Chinese makers
Aligner, Bracket, Orthodontic Class 1 Aligner Chewies 2025 30
Aligner, Sequential Class 2 Angel Aligner, Clear Aligner(EAB II) 2019 14
Clamp, Wire, Orthodontic Class 1 Removal tool 2025 27
Dental Hygiene Kit Class 1 Patient Kit 2025 12
Indirect Bonding Tray Class 1 Attachment Template 2026 6
Maintainer, Space Preformed, Orthodontic Class 1 Retainer 2020 18

Own-Brand Listings

Devices catalogued by Wuxi EA Medical Instruments Technologies Limited
Product Code Catalogue numbers
angel aligner NXC 5
Angel Aligner DYT 3
Lumosco NXC 1
Lumosco DYT 1
OrthoArch NXC 1
Angel Aligner QJJ 1
angel aligner Classic NXC 1
SimplyClear DYT 1
OrthoArch DYT 1
Impress DYT 1
Impress NXC 1
Angel Aligner NXZ 1
SimplyClear NXC 1
Progressive DYT 1

Clearances

2 clearances name Wuxi EA Medical Instruments Technologies Limited as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Wuxi EA Medical Instruments Technologies Limited or its listings
Clearance Decision date Product code Route Held by
K223517 2023-06-13 NXC Traditional This company
K203688 2021-10-08 NXC Traditional This company
K171674 2018-01-19 NXC Traditional Smile Development Corp

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer Device types
Wuxi Lyusmile IMP AND EXP Co., Ltd. 66
GE Medical Systems (China) Co., Ltd. 57
Gcmedica Enterprise Ltd.(Wuxi) 55
Emsrun Group 34
PRO-MED (Wuxi)IMP.& Exp.co., Ltd. 24
Wuxi Zontai Int’l Corporation Ltd. 22
Bioteke Corporation (Wuxi) Co., Ltd. 21
Inmed (Wuxi) Medical Device Co., Ltd. 17
Orthguide Medical Technology (Jiangsu) Co., Ltd. 17
Innovative Material & Devices, Inc. 13
Wuxi TP Orthodontics Material Co., Ltd. 9
Jiangsu Haize Medical Scientific Development Co., Ltd. 9
Visuscience Meditech Co., Ltd. 9
Wuxi Yushou Medical Appliances Co., Ltd. 8
Lincotek (Wuxi) Co., Ltd. 7
Linc Medipharm Limited 6
Wuxi Jiajian Medical Instrument Co., Ltd. 6
Jiangsu Xinbei Electrical Appliances Co., Ltd. 6
Wuxi Wemade Healthcare Products Co., Ltd. 6
Aupcon Medical Technology (Wuxi) Co., Ltd. 5
Wuxi Xindi Medical Technology Co., Ltd. 5
Goldcredit International Trading Co., Ltd. 5
Chison Medical Technologies Co., Ltd. 5
Wuxi Weigher Factory Co., Ltd. 4
Wuxi Kaishun Medical Device Manufacturing Co., Ltd. 4
Wuxi Hisky Medical Technologies Co., Ltd. 4
Wuxi FUN Gloves Co., Ltd. 3
Jiangsu Fulangte Medical Treatment Technology Co., Ltd. 3
Wuxi Phanpy Baby Products Co., Ltd. 3
Matrixed Reality Technology Co., Ltd. 3
Wuxi Wiseu IMP&EXP Co., Ltd. 3
Wuxi Biohermes BIO & Medical Technology Co., Ltd. 3
JHQ NEW Material Technology Co., Ltd. 3
Farstar (Wuxi) Medical Equipment Co., Ltd. 2
Wuxi Nest Biotechnology Co., Ltd. 2
Siemens X-RAY Vacuum Technology Ltd. 2
Biox Instruments Co Ltd 2
Broad Origin Inc. 2
Wuxi Sunmaxx Technology Co., Ltd. 2
Wuxi Medical Instrument Factory Co., Ltd. 1
Cmeos Medical SCI & Tech (Wuxi) Co., Ltd. 1
Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd. 1
Wuxi Vision PRO Ltd 1
Pulnovo Medical (Wuxi) Co., Ltd. 1
Olemy Laser Technology Ltd 1
Varex Imaging Equipment (China) Co., Ltd. 1
Gaush Neotech Ltd. 1
Wuxi Guochen Medical Technology Co., Ltd. 1
Gaofeng Medical Equipment (Wuxi) Co., Ltd. 1
Jiangsu Rayer Medical Technology Co., Ltd. 1
BM Medical Technology Co., Ltd. 1
Wuxi Allied Technologies, Inc. 1

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