Pure Global AI
EUDAMED registration 08800033428770No

Orthodontic bracket, metal

Osstem Orthodontics Inc.Class IIaEU EUDAMEDTrade name: YES Bracket (YES2, MISTRAL)
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
Q010403
Trade name
YES Bracket (YES2, MISTRAL)
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
08800033428770
Basic UDI
B-08800033428770
Version date
May 10, 2023
Manufacturer last update
September 21, 2022
Active status
No
Manufacturer
Manufacturer name
Osstem Orthodontics Inc.
Country
Republic of Korea
Country type
NON_EU
Address
13 Ojeongongeop-gil Uiwang-si
Email
inkwak@osstemortho.com
Authorized representative
Name
AR Experts B.V.
SRN
NL-AR-000023989
Country
Netherlands
Address
7 Amerlandseweg Breukelen
Email
info@ar-experts.eu
Telephone
+31889951333
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Netherlands
Market available
France:2022-01-01~None, Germany:2022-01-01~None, Italy:2020-01-01~None, Netherlands:2014-01-01~None, Poland:2016-01-01~None, Turkey:2021-01-01~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

ORTHODONTIC BRACKETS AND BUTTONS

About this record

Access comprehensive regulatory information for Orthodontic bracket, metal in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 08800033428770 and manufactured by Osstem Orthodontics Inc. in Republic of Korea.

This page provides complete registration details including trade name (YES Bracket (YES2, MISTRAL)), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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.