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Myofunctional orthodontic appliances - EUDAMED Registration 19330944000414

Access comprehensive regulatory information for Myofunctional orthodontic appliances in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 19330944000414 and manufactured by Myofunctional Research Co. in Australia.

This page provides complete registration details including trade name (Myobrace K1), 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.

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EUDAMED Official Data
Class I
19330944000414
No
Myofunctional orthodontic appliances
Trade Name: Myobrace K1
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Device Description (EMDN)

ORTHODONTIC DEVICES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q010499
Trade Name
Myobrace K1
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
19330944000414
Basic UDI
9330944A0000001MM
Active Status
No
Manufacturer
Country
Australia
Country Type
NON_EU
Address
44 Siganto Drive Gold Coast
Email
regulatory@myoresearch.com
Authorized Representative
SRN
NL-AR-000003918
Country
Netherlands
Address
21c Gompenstraat Waalwijk
Email
info@myoresearch.nl
Telephone
+31416651696
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Netherlands
Market Available
Netherlands:2013-05-28~None
Device Characteristics
Human Tissues
No
Animal Tissues
No