Pure Global

U2 Total Knee System Tibial Augment Set, Screw Locking, #2, 15mm Thick, Left Medial / Right Lateral - EUDAMED Registration 04712771501926

Access comprehensive regulatory information for U2 Total Knee System Tibial Augment Set, Screw Locking, #2, 15mm Thick, Left Medial / Right Lateral in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 04712771501926 and manufactured by United Orthopedic Corporation in Taiwan.

This page provides complete registration details including trade name (U2 Total Knee System), 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class IIb
04712771501926
No
U2 Total Knee System Tibial Augment Set, Screw Locking, #2, 15mm Thick, Left Medial / Right Lateral
Trade Name: U2 Total Knee System
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

KNEE PROSTHESES AUGMENTS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P09098001
Trade Name
U2 Total Knee System
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
04712771501926
Basic UDI
B-04712771501926
Version Date
December 31, 2024
Manufacturer Last Update
September 18, 2024
Active Status
No
Manufacturer
Country
Taiwan
Country Type
NON_EU
Address
No. 16 Luke 1st Rd., Luzhu Dist., Kaohsiung City, Taiwan 82151 Kaohsiung
Email
regulatory@Unitedorthopedic.com
Authorized Representative
SRN
DE-AR-000006218
Country
Germany
Address
71 Langenhagener StraรŸe Langenhagen
Email
info@mdi-europa.com
Regulatory Information
Competent Authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
France
Market Available
France:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No