Pure Global

Orthodontic bands and attachments - EUDAMED Registration 06936949215110

Access comprehensive regulatory information for Orthodontic bands and attachments 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 06936949215110 and manufactured by Innovative Material and Devices, Inc in China.

This page provides complete registration details including 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
06936949215110
No
Orthodontic bands and attachments
EU EUDAMED Registered Medical Device
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

ORTHODONTIC BANDS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q010402
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06936949215110
Basic UDI
693694921786-22082F
Version Date
April 26, 2023
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
Germany
Market Available
Germany:2022-02-03~2022-02-04, Poland:2023-04-01~2023-04-08
Device Characteristics
Human Tissues
No
Animal Tissues
No