Changsha Airdoc Health Technology Co., Ltd.

FDA Device Registration & Listing · Changsha Hunan, CN · Registration 3023810198

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
3023810198
FEI Number
3023810198
Entity Name
Changsha Airdoc Health Technology Co., Ltd.
City/State/Country
Changsha Hunan, CN
Establishment Address
From Girder No. 3 to Girder No. 13 and Room 501-502, 5th Floor, Building B, Industrial Plant, Otto Technology, Second Industrial Park, No. 13, Huanlian Road, Dongfanghong Street, Changsha Hi-tech Development Zone, Changsha Hunan 410221, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Changsha Airdoc Health Technology Co., Ltd. (Owner Number: 10085517)
Owner / Operator Contact Address
From Girder No. 3 to Girder No. 13 and Room 501-502, 5th Floor, Building B, Industrial Plant, Otto Technology, Second Industrial Park, No. 13, Huanlian Road, Dongfanghong Street, Changsha Hi-tech Development Zone, Changsha, CN-HN 410221, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

fundus camera AI-FD16M / fundus cameraAI-FD16M YT-VT2024

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PJZ Camera, Ophthalmic, General-Use Ophthalmic Class 2 886.1120 2022-06-27
SBN Digital Therapy Device For Convergence Insufficiency Ophthalmic Class 1 886.1290 2025-02-09

Official Correspondent

Xiaoli Cao

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Changsha Airdoc Health Technology Co., Ltd.
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 3023810198. Last updated year: 2026. Please use registration number 3023810198 when referencing this establishment in official correspondence.
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