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Radiological Positioning Holders, Cradles and Accessories - EUDAMED Registration 04719879740516

Access comprehensive regulatory information for Radiological Positioning Holders, Cradles and Accessories 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 04719879740516 and manufactured by Blessing Cathay Corporation in Taiwan.

This page provides complete registration details including trade name (Oral Bite), manufacturer information, authorized representative details, competent authority (Agencia Espaรฑola de Medicamentos y Productos Sanitarios), 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
04719879740516
No
Radiological Positioning Holders, Cradles and Accessories
Trade Name: Oral Bite
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Device Description (EMDN)

VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z11019099
Trade Name
Oral Bite
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
04719879740516
Basic UDI
471987974RT58
Active Status
No
Manufacturer
Country
Taiwan
Country Type
NON_EU
Address
2F, No. 310 Jianguo 1st Road New Taipei City
Email
info@bcc.taipei
Authorized Representative
SRN
ES-AR-000000293
Country
Spain
Address
C/ Horacio Lengo N18 Mรกlaga
Email
info@cmcmedicaldevices.com
Telephone
+34951214054
Regulatory Information
Competent Authority
Agencia Espaรฑola de Medicamentos y Productos Sanitarios
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Spain
Device Characteristics
Human Tissues
No
Animal Tissues
No