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ST.LEGER NEO MOBILE BEARING P/S TIBIAL INSERT (XL) 60mm 17mm - EUDAMED Registration 05051659062647

Access comprehensive regulatory information for ST.LEGER NEO MOBILE BEARING P/S TIBIAL INSERT (XL) 60mm 17mm in the European Union medical device market through Pure Global AI's free database. This Class III device is registered with EU EUDAMED under Primary DI 05051659062647 and manufactured by Covision Medical Technologies Ltd. in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (COVISION), manufacturer information, authorized representative details, competent authority (Turkish Medicine and Medical Devices Agency), 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 III
05051659062647
No
ST.LEGER NEO MOBILE BEARING P/S TIBIAL INSERT (XL) 60mm 17mm
Trade Name: COVISION
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Device Description (EMDN)

BICOMPARTMENTAL PRIMARY IMPLANT MOBILE BEARING TIBIAL INSERTS

Device Classification
Risk Class
Class III
CND Nomenclatures Code
P090903020201
Trade Name
COVISION
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05051659062647
Basic UDI
B-05051659062647
Version Date
June 17, 2023
Manufacturer Last Update
November 24, 2022
Active Status
No
Manufacturer
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
Lawn Rd., Carlton Industrial Park, Carlton In Lindrick, Worksop Nottinghamshire
Email
mike.rimmer@covision-medical.co.uk
Authorized Representative
SRN
IE-AR-000031129
Country
Ireland
Address
Coliemore House Coliemore Road Dublin
Email
cmtireland@covision-medical.co.uk
Telephone
+44(0)1909733737
Regulatory Information
Competent Authority
Turkish Medicine and Medical Devices Agency
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Austria
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