EU Manufacturer 🇨🇳 China Active

Beijing Honghugaoxiang Science and Technology Development Co.,Ltd.

SRN: CN-MF-000024518 · 5 Building On The West Side,No.3, Tiangui Street,Zhongguancun Science Park,Daxing Biomedical Industry Base,Daxing District, 102600 Beijing, China

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Basic UDI-DIs

Total Devices

On Market

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Watch Beijing Honghugaoxiang Science and Technology Development Co.,Ltd. for changes

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Basic Information

Address: 5 Building On The West Side,No.3, Tiangui Street,Zhongguancun Science Park,Daxing Biomedical Industry Base,Daxing District, 102600 Beijing, China
Email: [email protected]

Regulatory Overview

Regulation

Eu Mdd 84

Eu Mdr 3

Classification

Eu Md Class 2b 83

Eu Md Class 1 3

Eu Md Class 2a 1

Device Types

Certificate Health

Total

Valid

Expiring < 6mo

Expired / Withdrawn

Certificates by Expiry Year

Type	Number	Notified Body	Legislation	Issue Date	Expiry Date	Status
MDD Annex II (excluding section 4)	HD60147168	TÜV Rheinland LGA Products GmbH			May 26, 2024
MDD Annex II (excluding section 4)	HD 60147168	TÜV Rheinland LGA Products GmbH			May 26, 2024

Market Presence

Devices from this manufacturer are available in 3 countries across Europe.

🇮🇪 Ireland 🇮🇸 Iceland 🇬🇧 United Kingdom

Device Portfolio

Name	Regulation	Classification	Market Status	Certificates
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1
Bipolar Open-surgery Electrosurgical Handpiece (including electrode) for Single-use	EU MDD	Eu Md Class 2b	On Market	1

View all 87 devices →

PRRC

Name

Yunfei Gao

Country

🇨🇳 China

Authorized Representative #1

Name

SUNGO Europe B.V.

Country

🇳🇱 Netherlands

Authorized Representative #2

Name

MedPath GmbH

Country

🇩🇪 Germany

Notified Bodies

TÜV Rheinland LGA Products GmbH

2 certs

Competent Authority

Name

DE/CA304 - Marktüberwachung Medizinprodukte Bayern

Country

🇩🇪 Germany

More about this competent authority →

PSUR Report

Search FDA adverse events and recalls name-matched to Beijing Honghugaoxiang Science and Technology Development Co.,Ltd. — useful for PSUR and supplier checks.

Check FDA post-market data

Quick Links

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