Pure Global

Orthodontic Archwires - EUDAMED Registration 06957067094463

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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class IIa
06957067094463
No
Orthodontic Archwires
Trade Name: Orthodontic Archwires
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

ORTHODONTIC WIRES

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q010405
Trade Name
Orthodontic Archwires
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06957067094463
Basic UDI
695706701462-1631MF
Version Date
August 14, 2022
Manufacturer Last Update
March 22, 2021
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
3F, Building #5, No. 615 Fengdeng Rd., Jiading District, Shanghai, China Shanghai
Email
wang.weina@imdmedical.com
Authorized Representative
SRN
NL-AR-000000121
Country
Netherlands
Address
Koningin Julianaplein 10, 1e Verd The Hague
Email
peter@lotusnl.com
Regulatory Information
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
Device Characteristics
Human Tissues
No
Animal Tissues
No