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Electronic Muscle Stimulator - EUDAMED Registration 06950940802452

Access comprehensive regulatory information for Electronic Muscle Stimulator 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 06950940802452 and manufactured by Shenzhen OSTO Medical Technology Company Limited in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24), 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
06950940802452
Yes
Electronic Muscle Stimulator
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z12062801
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
06950940802452
Basic UDI
695094080001GT
Version Date
January 15, 2025
Manufacturer Last Update
August 14, 2023
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
2104, Unit4, Building2, Zhongxin Longsheng Square, NO. 219 Shenshan Road (Longgang Section), Longxin Community, Baolong Street, Longgang District Shenzhen
Email
sales06@szosto.com
Authorized Representative
SRN
DE-AR-000007996
Country
Germany
Address
11 Koenigsberger Strasse Muenster Hessen
Email
contact@phoenix-medtech.de
Telephone
004960714977513
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Germany:2025-03-13~2025-03-14
Device Characteristics
Human Tissues
No
Animal Tissues
No