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IH LT Abutment - EUDAMED Registration 08800041367603

Access comprehensive regulatory information for IH LT Abutment 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 08800041367603 and manufactured by MF / SEWONMEDIX Inc. in Republic of Korea.

This page provides complete registration details including trade name (IH LT Abutment), 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 IIb
08800041367603
No
IH LT Abutment
Trade Name: IH LT Abutment
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Device Description (EMDN)

DENTAL IMPLANTS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P01020101
Trade Name
IH LT Abutment
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08800041367603
Basic UDI
B-08800041367603
Version Date
October 17, 2024
Manufacturer Last Update
May 20, 2024
Active Status
No
Manufacturer
Manufacturer Name
MF / SEWONMEDIX Inc.
Country
Republic of Korea
Country Type
NON_EU
Address
#29 Sasang-ro 375beon-gil Busan
Email
info@sewonmedix.com
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
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Poland
Market Available
Poland:2017-03-22~None
Device Characteristics
Human Tissues
No
Animal Tissues
No