Pure Global

Perfect MamaTENS Electrodes - EUDAMED Registration 05033435130092

Access comprehensive regulatory information for Perfect MamaTENS Electrodes 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 05033435130092 and manufactured by TensCare Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (New mamaTENS Electrodes), manufacturer information, authorized representative details, competent authority (Malta Medicines Authority), 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class I
05033435130092
No
Perfect MamaTENS Electrodes
Trade Name: New mamaTENS Electrodes
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

TENS SYSTEM ELECTRODES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
N010201
Trade Name
New mamaTENS Electrodes
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05033435130092
Basic UDI
5033435E00010WK
Active Status
No
Manufacturer
Manufacturer Name
TensCare Ltd
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
9 Blenheim Road London
Email
QA@tenscare.co.uk
Authorized Representative
SRN
MT-AR-000000234
Country
Malta
Address
Tower Street Swatar
Email
prrc@advena.mt
Regulatory Information
Competent Authority
Malta Medicines Authority
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Denmark
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, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No