Orthodontic Brackets
- Risk class
- Class IIa
- CND nomenclatures code
- Q010403
- Trade name
- Crisel
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06941673547420
- Basic UDI
- 69416735BRK735ND
- Active status
- No
- Manufacturer name
- ASTAR ORTHODONTICS INC.
- Country
- China
- Country type
- NON_EU
- Address
- South Zhongshan Road Section 1 Shanghai
- service@astar-ortho.com.cn
- SRN
- PT-AR-000021480
- Country
- Portugal
- Address
- LOTE 13, LOJA A RUA DOS BOMBEIROS VOLUNTÁRIOS, ALCABIDECHE
- geral@bioconcept.pt
- Competent authority
- INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, 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, Türkiye:None~None
- Human tissues
- No
- Animal tissues
- No
ORTHODONTIC BRACKETS AND BUTTONS
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 06941673547420 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 Saúde, 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.