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EUDAMED registration 08800136100009No

Ceramic Etchant 5, Ceramic Etchant 9, Zirconia Etchant, Zirconia Etchant Cloud System

MEDIFIVEClass IEU EUDAMEDTrade name: Ceramic Etchant 5
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Q010299
Trade name
Ceramic Etchant 5
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
08800136100009
Basic UDI
88001361MF00023J
Version date
July 19, 2022
Manufacturer last update
August 10, 2023
Active status
No
Manufacturer
Manufacturer name
MEDIFIVE
Country
Republic of Korea
Country type
NON_EU
Address
84 Namdongdong-ro Incheon
Email
medifive@medifive.com
Authorized representative
Name
Certification Experts
SRN
NL-AR-000000235
Country
Netherlands
Address
7 Amerlandseweg Breukelen
Email
e.unk@certification-experts.com
Telephone
+31850073210
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Spain
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

PROSTHETIC DENTISTRY DEVICES - OTHER

About this record

Access comprehensive regulatory information for Ceramic Etchant 5, Ceramic Etchant 9, Zirconia Etchant, Zirconia Etchant Cloud System 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 08800136100009 and manufactured by MEDIFIVE in Republic of Korea.

This page provides complete registration details including trade name (Ceramic Etchant 5), 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.