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BalanceTutor - EUDAMED Registration 07290019733829

Access comprehensive regulatory information for BalanceTutor in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 07290019733829 and manufactured by MediTouch Ltd in Israel.

This page provides complete registration details including trade name (HMBT100 A), manufacturer information, authorized representative details, competent authority (Danish Medicines Agency, Pharmacovigilance & Medical Devices), 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 I
07290019733829
No
BalanceTutor
Trade Name: HMBT100 A
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Device Description (EMDN)

PHYSIOTHERAPY EQUIPMENT

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z120602
Trade Name
HMBT100 A
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
07290019733829
Basic UDI
7290019733BT100U9
Version Date
June 20, 2023
Manufacturer Last Update
June 22, 2022
Active Status
No
Manufacturer
Manufacturer Name
MediTouch Ltd
Country
Israel
Country Type
NON_EU
Address
1 Nirim St. Tnuvot
Email
info@meditouch.co.il
Authorized Representative
SRN
DK-AR-000017664
Country
Denmark
Address
52 2 th Blokland Albertslund
Email
info@techstandi.com
Telephone
08000016832
Regulatory Information
Competent Authority
Danish Medicines Agency, Pharmacovigilance & Medical Devices
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Poland
Market Available
Sweden:None~None, Turkey:None~None, United Kingdom (Northern Ireland only):None~None, Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No