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Ankle foot orthosis - EUDAMED Registration 05052893002635

Access comprehensive regulatory information for Ankle foot orthosis 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 05052893002635 and manufactured by Trulife Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Matrix L-Pace AFO - Left Large), manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), 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
05052893002635
No
Ankle foot orthosis
Trade Name: Matrix L-Pace AFO - Left Large
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Device Description (EMDN)

ENERGY RETURN ANKLE-FOOT ORTHOSES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Y06120602
Trade Name
Matrix L-Pace AFO - Left Large
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05052893002635
Basic UDI
5052893CFMCQ
Version Date
March 05, 2024
Manufacturer Last Update
March 20, 2024
Active Status
No
Manufacturer
Manufacturer Name
Trulife Ltd
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
41 Amos Road Sheffield
Email
demsden@trulife.com
Authorized Representative
SRN
DE-AR-000005430
Country
Germany
Address
41 Schiffgraben Hannover
Email
info@mdssar.com
Regulatory Information
Competent Authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Ireland
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