Orthodontic Archwires
- Risk class
- Class IIa
- CND nomenclatures code
- Q010405
- Trade name
- Orthodontic Archwires
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06957067094463
- Basic UDI
- 695706701462-1631MF
- Version date
- August 14, 2022
- Manufacturer last update
- March 22, 2021
- Active status
- No
- Manufacturer name
- Innovative Material and Devices, Inc
- Country
- China
- Country type
- NON_EU
- Address
- 3F, Building #5, No. 615 Fengdeng Rd., Jiading District, Shanghai, China Shanghai
- wang.weina@imdmedical.com
- Name
- Lotus NL B.V.
- SRN
- NL-AR-000000121
- Country
- Netherlands
- Address
- Koningin Julianaplein 10, 1e Verd The Hague
- peter@lotusnl.com
- Competent authority
- Ministerie van Volksgezondheid, Welzijn en Sport
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- France
- Market available
- France:2022-08-10~2022-08-17, Italy:2022-08-12~2022-08-19
- Human tissues
- No
- Animal tissues
- No
ORTHODONTIC WIRES
Access comprehensive regulatory information for Orthodontic Archwires 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 06957067094463 and manufactured by Innovative Material and Devices, Inc in China.
This page provides complete registration details including trade name (Orthodontic Archwires), 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.