Pure Global

Hearing Aid - EUDAMED Registration 06971094537816

Access comprehensive regulatory information for Hearing Aid in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 06971094537816 and manufactured by Huizhou Jinghao Medical Technology Co.,Ltd in China.

This page provides complete registration details including trade name (Hearing Aid), manufacturer information, authorized representative details, competent authority (DE/CA304 - Marktรผberwachung Medizinprodukte Bayern), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class IIa
06971094537816
Yes
Hearing Aid
Trade Name: Hearing Aid
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

HEARING AID IN THE-EAR (ITE)

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Y2145060201
Trade Name
Hearing Aid
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06971094537816
Basic UDI
B-06971094537816
Version Date
September 20, 2024
Manufacturer Last Update
March 30, 2024
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
Floor 1st, 4th, 5th, 9th & 10th, No. 1 Building, No. 207, South SiHuan Rd, ZhongKai Hi-tech District Huizhou City, Guangdong Province
Email
maoyuanxia@jinghao.info
Authorized Representative
SRN
DE-AR-000000087
Country
Germany
Address
8 Mies-van-der-Rohe-Strasse Munich
Email
info@medpath.pro
Telephone
+49 (0) 89 8130 6837
Regulatory Information
Competent Authority
DE/CA304 - Marktรผberwachung Medizinprodukte Bayern
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Germany
Market Available
Germany:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No