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Hearing aids (Digital) - EUDAMED Registration 06971094539292

Access comprehensive regulatory information for Hearing aids (Digital) 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 06971094539292 and manufactured by Huizhou Jinghao Medical Technology Co.,Ltd in China.

This page provides complete registration details including trade name (Hearing aids), 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.

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EUDAMED Official Data
Class IIa
06971094539292
Yes
Hearing aids (Digital)
Trade Name: Hearing aids
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Device Description (EMDN)

HEARING AID IN THE-EAR (ITE)

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Y2145060201
Trade Name
Hearing aids
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06971094539292
Basic UDI
697109453DigitalV2
Version Date
February 18, 2025
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
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Germany:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No