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Perfect PFE - EUDAMED Registration 05033435132768

Access comprehensive regulatory information for Perfect PFE 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 05033435132768 and manufactured by TensCare Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Pelvi+), 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.

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EUDAMED Official Data
Class IIa
05033435132768
Yes
Perfect PFE
Trade Name: Pelvi+
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Device Description (EMDN)

PELVIC FLOOR REHABILITATION DEVICES - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
U070399
Trade Name
Pelvi+
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05033435132768
Basic UDI
5033435K00053ZK
Version Date
March 05, 2025
Manufacturer Last Update
February 27, 2025
Active Status
Yes
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
France
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