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HandTutor - EUDAMED Registration 05065016488070

Access comprehensive regulatory information for HandTutor 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 05065016488070 and manufactured by TMA MEDICAL EQUIPMENT LTD in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (HandTutor), 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
05065016488070
Yes
HandTutor
Trade Name: HandTutor
Pure Global
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Device Description (EMDN)

PHYSIOTHERAPY EQUIPMENT

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z120602
Trade Name
HandTutor
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
05065016488070
Basic UDI
5065016488HandtutorLU
Version Date
July 10, 2023
Manufacturer Last Update
May 16, 2023
Active Status
Yes
Manufacturer
Manufacturer Name
TMA MEDICAL EQUIPMENT LTD
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
177 Ashfield Avenue, Bushey
Email
tmamedical.uk@gmail.com
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
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, Sweden:None~None, Turkey:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No