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Medial Rotation Knee All Poly Tibia - EUDAMED Registration 05055455504097

Access comprehensive regulatory information for Medial Rotation Knee All Poly Tibia 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 05055455504097 and manufactured by MatOrtho Limited in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Medial Rotation Knee), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), 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
05055455504097
No
Medial Rotation Knee All Poly Tibia
Trade Name: Medial Rotation Knee
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Device Description (EMDN)

BICOMPARTMENTAL PRIMARY IMPLANT TIBIAL COMPONENTS, MONOBLOCK MADE OF POLYETHYLENE

Device Classification
Risk Class
Class III
CND Nomenclatures Code
P090903020301
Trade Name
Medial Rotation Knee
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05055455504097
Basic UDI
B-05055455504097
Version Date
May 17, 2022
Manufacturer Last Update
June 16, 2021
Active Status
No
Manufacturer
Manufacturer Name
MatOrtho Limited
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
19/20 Mole Business Park Leatherhead
Email
info@matortho.com
Authorized Representative
SRN
IE-AR-000006856
Country
Ireland
Address
The Black Church Saint Mary's Place North Dublin
Email
ar@matortho.eu
Telephone
+441372224200
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
United Kingdom (Northern Ireland only)
Market Available
United Kingdom (Northern Ireland only):2011-08-01~None
Device Characteristics
Human Tissues
No
Animal Tissues
No