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Sleep Apnoea Breathing Therapy Device(CPAP Devices) - EUDAMED Registration 06972955510009

Access comprehensive regulatory information for Sleep Apnoea Breathing Therapy Device(CPAP Devices) in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 06972955510009 and manufactured by Shenzhen Yamind Medical Technology Co., Ltd. in China.

This page provides complete registration details including trade name (Yamind), manufacturer information, authorized representative details, competent authority (DE/CA38 - Regierungspräsidium Karlsruhe), 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 IIb
06972955510009
Yes
Sleep Apnoea Breathing Therapy Device(CPAP Devices)
Trade Name: Yamind
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Device Description (EMDN)

ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
Q03010299
Trade Name
Yamind
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
06972955510009
Basic UDI
B-06972955510009
Version Date
August 03, 2023
Manufacturer Last Update
December 19, 2022
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
Xili Street, Nanshan District Shenzhen, GuangDong
Email
libaohong@yamind.com.cn
Authorized Representative
SRN
DE-AR-000009077
Country
Germany
Address
34/2 Obere Seegasse Heidelberg
Email
info@llins-service.com
Regulatory Information
Competent Authority
DE/CA38 - Regierungspräsidium Karlsruhe
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Germany
Market Available
Germany:2023-02-16~2024-05-26, Romania:2023-02-16~2024-05-26
Device Characteristics
Human Tissues
No
Animal Tissues
No