HYGEA MEDICAL TECHNOLOGY CO., LTD.

FDA Device Registration & Listing · Beijing, CN · Registration 3039443404

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
3039443404
FEI Number
3039443404
Entity Name
HYGEA MEDICAL TECHNOLOGY CO., LTD.
City/State/Country
Beijing, CN
Establishment Address
Floors 1 to 4 of Building 31, Floors 1 to 3 of Building 32,No. 69 Qingfeng West Road, Daxing District, Beijing 102600, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Hygea Medical Technology Co., Ltd. (Owner Number: 10093771)
Owner / Operator Contact Address
RM1101, 1/F, Building 17, No.18, 3rd South Zhongguancun Street, Haidian District, Beijing, Beijing, CN-BJ 100190, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233140
PMA Number
N/A

All Registered Proprietary Names

Sterile Co-Ablation Probe Co-Ablation System Sterile Microwave Ablation Probe Microwave Ablation Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2025-07-11
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2025-07-11

Official Correspondent

Jiang Xingtong

US Agent Details

James Wang Business: LLINS TECHNOLOGY INC Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

Hygea Medical Technology Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K190651 Erbe Elektromedizin GmbH ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter 2020-01-07
K760953 Spembly Medical , Ltd. DEEP FREEZE SYSTEM (DFS-30) 1976-11-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0210-2022 Covidien Llc 2
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039443404. Last updated year: 2026. Please use registration number 3039443404 when referencing this establishment in official correspondence.
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