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Spare Mirror and Keys - EUDAMED Registration 04719879278668

Access comprehensive regulatory information for Spare Mirror and Keys 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 04719879278668 and manufactured by ACME TOOLING TECHNOLOGY CO., LTD. in Taiwan.

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.

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EUDAMED Official Data
Class I
04719879278668
No
Spare Mirror and Keys
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

DENTAL MIRRORS AND HANDLES, REUSABLE

Device Classification
Risk Class
Class I
CND Nomenclatures Code
L160201
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
04719879278668
Basic UDI
471987927SM49
Version Date
January 18, 2025
Manufacturer Last Update
October 25, 2024
Active Status
No
Manufacturer
Country
Taiwan
Country Type
NON_EU
Address
41-3 Fuxing Rd. Changhua County, Fuxing Township, Waipu Vil.
Email
motranser@yunghau.com
Authorized Representative
SRN
NL-AR-000002066
Country
Netherlands
Address
Zonnehof 36 Nootdorp
Email
office@kingsmead-service.com
Telephone
+31(0) 64 6571 005
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Bulgaria
Market Available
Bulgaria:None~None, France:None~None, Germany:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Spain:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No