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EUDAMED registration 08809744961705No

OAS-T1208-LN

BioMaterials Korea, Inc.Class IIbEU EUDAMEDTrade name: Orthodontic Anchor Screw
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIb
CND nomenclatures code
Q010499
Trade name
Orthodontic Anchor Screw
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
08809744961705
Basic UDI
B-08809744961705
Version date
February 12, 2025
Manufacturer last update
October 08, 2024
Active status
No
Manufacturer
Manufacturer name
BioMaterials Korea, Inc.
Country
Republic of Korea
Country type
NON_EU
Address
Hanam-si, Gyeonggi-do
Email
info@biomk.com
Authorized representative
Name
KTR Europe GmbH
SRN
DE-AR-000005685
Country
Germany
Address
77 Mergenthalerallee Eschborn
Email
ktreurope@ktreurope.de
Telephone
+49 6196 887 170
Regulatory information
Competent authority
DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Spain
Market available
Spain:2017-01-27~2024-12-31
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

ORTHODONTIC DEVICES - OTHER

About this record

Access comprehensive regulatory information for OAS-T1208-LN 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 08809744961705 and manufactured by BioMaterials Korea, Inc. in Republic of Korea.

This page provides complete registration details including trade name (Orthodontic Anchor Screw), manufacturer information, authorized representative details, competent authority (DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt), 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.