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Orthodontic Brackets - EUDAMED Registration 06941673547475

Access comprehensive regulatory information for Orthodontic Brackets 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 06941673547475 and manufactured by ASTAR ORTHODONTICS INC. in China.

This page provides complete registration details including trade name (Crisel), manufacturer information, authorized representative details, competent authority (INFARMED - Autoridade Nacional do Medicamento e Produtos de Saรบde, I.P.), 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
06941673547475
No
Orthodontic Brackets
Trade Name: Crisel
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Device Description (EMDN)

ORTHODONTIC BRACKETS AND BUTTONS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q010403
Trade Name
Crisel
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06941673547475
Basic UDI
69416735BRK735ND
Active Status
No
Manufacturer
Manufacturer Name
ASTAR ORTHODONTICS INC.
Country
China
Country Type
NON_EU
Address
South Zhongshan Road Section 1 Shanghai
Email
service@astar-ortho.com.cn
Authorized Representative
SRN
PT-AR-000021480
Country
Portugal
Address
LOTE 13, LOJA A RUA DOS BOMBEIROS VOLUNTรRIOS, ALCABIDECHE
Email
geral@bioconcept.pt
Regulatory Information
Competent Authority
INFARMED - Autoridade Nacional do Medicamento e Produtos de Saรบde, I.P.
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Portugal
Market Available
Italy:None~None, Portugal:None~None, Spain:None~None, Tรผrkiye:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No