WUXI EA MEDICAL INSTRUMENTS TECHNOLOGIES LIMITED

FDA Device Registration & Listing · Wuxi Jiangsu, CN · Registration 3013556527

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013556527
FEI Number
3013556527
Entity Name
WUXI EA MEDICAL INSTRUMENTS TECHNOLOGIES LIMITED
City/State/Country
Wuxi Jiangsu, CN
Establishment Address
1F, building 1 and building 2, No. 1619, Huishan Avenue, Huishan Economic Development Zone, Wuxi Jiangsu 214174, CN
Establishment Type(s)
Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Wuxi EA Medical Instruments Technologies Limited (Owner Number: 10060304)
Owner / Operator Contact Address
No. 1619, Huishan Avenue, Huishan Economic Development Zone, Wuxi, China 214000, Wuxi, CN-NOTA 214000, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K171674
PMA Number
N/A

All Registered Proprietary Names

Attachment Template Patient Kit Angel Aligner Clear Aligner(EAB II) Aligner Chewies Retainer Clear Aligner(EAB II)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QJJ Indirect Bonding Tray Dental Class 1 872.5410 2026-05-17
NXZ Dental Hygiene Kit Dental Class 1 872.6855 2025-07-29
NXC Aligner, Sequential Dental Class 2 872.5470 2023-06-19
ECQ Aligner, Bracket, Orthodontic Dental Class 1 872.4565 2025-07-15
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 2020-07-09
NXC Aligner, Sequential Dental Class 2 872.5470 2021-11-02
NXC Aligner, Sequential Dental Class 2 872.5470 2019-04-23

Official Correspondent

Jessica Luo

US Agent Details

Bill Jacqmein Email: bjacqmein@primepathmedtech.com Phone: (404) 2166190

Related Public Records

Same Entity

Wuxi EA Medical Instruments Technologies Limited
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013556527. Last updated year: 2026. Please use registration number 3013556527 when referencing this establishment in official correspondence.
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