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Walkbot_P - EUDAMED Registration 08800079500041

Access comprehensive regulatory information for Walkbot_P 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 08800079500041 and manufactured by P&S Mechanics Co.,Ltd. in Republic of Korea.

This page provides complete registration details including trade name (Walkbot), manufacturer information, authorized representative details, competent authority (DE/CA24 - Regierungsprรคsidium Darmstadt Abteilung Arbeitsschutz und Umwelt), 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
08800079500041
Yes
Walkbot_P
Trade Name: Walkbot
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Device Description (EMDN)

ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z120616
Trade Name
Walkbot
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08800079500041
Basic UDI
880007950004CP
Version Date
August 21, 2023
Manufacturer Last Update
February 28, 2023
Active Status
Yes
Manufacturer
Manufacturer Name
P&S Mechanics Co.,Ltd.
Country
Republic of Korea
Country Type
NON_EU
Address
70 Rm. 509, Seonyu-ro Seoul
Email
servicekr@walkbot.co.kr
Authorized Representative
SRN
DE-AR-000007685
Country
Germany
Address
The Squaire 12, At the airport, Frankfurt
Email
miki.m@arazygroup.com
Telephone
+49 (0) 69 95932-5090
Regulatory Information
Competent Authority
DE/CA24 - Regierungsprรคsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Spain
Market Available
Croatia:None~None, Romania:None~None, Spain:None~None, Turkey:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No