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A Mobile/fixed screen device - EUDAMED Registration 04711299770067

Access comprehensive regulatory information for A Mobile/fixed screen device 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 04711299770067 and manufactured by Machan International Co., Ltd. in Taiwan.

This page provides complete registration details including trade name (BAILIDA), 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
04711299770067
No
A Mobile/fixed screen device
Trade Name: BAILIDA
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Device Description (EMDN)

GENERAL MEDICINE INSTRUMENTS - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z120499
Trade Name
BAILIDA
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
04711299770067
Basic UDI
471024325FS01-FS063A
Version Date
March 17, 2022
Manufacturer Last Update
March 16, 2022
Active Status
No
Manufacturer
Country
Taiwan
Country Type
NON_EU
Address
No.352, Tama Rd., Waipu Dist. Taichung City
Email
chihmin@machangroup.com
Authorized Representative
SRN
NL-AR-000002750
Country
Netherlands
Address
130 Weena Zuid Rotterdam
Email
info@luanamed.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
Device Characteristics
Human Tissues
No
Animal Tissues
No