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Miso Ideal Ceramic Bracket - EUDAMED Registration 08800022216043

Access comprehensive regulatory information for Miso Ideal Ceramic Bracket 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 08800022216043 and manufactured by HT Co., Ltd. in Republic of Korea.

This page provides complete registration details including 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.

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EUDAMED Official Data
Class IIa
08800022216043
No
Miso Ideal Ceramic Bracket
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

ORTHODONTIC BRACKETS AND BUTTONS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q010403
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08800022216043
Basic UDI
880002220MisoIdealWF
Version Date
April 11, 2023
Manufacturer Last Update
April 14, 2022
Active Status
No
Manufacturer
Manufacturer Name
HT Co., Ltd.
Country
Republic of Korea
Country Type
NON_EU
Address
10, Sinjeong-ro 159beon-gil, Giheung-gu Yongin-si, Gyeonggi-do
Email
htdental@htdental.co
Authorized Representative
SRN
DE-AR-000005875
Country
Germany
Address
16 Sachsenhausener Str. Schwalbach am Taunus
Email
info@javitech.de
Telephone
+49 176 7298 9240
Regulatory Information
Competent Authority
DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Turkey:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No