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EUDAMED registration 08809380052577No

Defogger Anti-fog System

The Standard. Co., Ltd.Class IIaEU EUDAMEDTrade name: Defogger Anti-fog System
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
Z12029015
Trade name
Defogger Anti-fog System
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
08809380052577
Basic UDI
B-08809380052577
Version date
December 13, 2021
Manufacturer last update
June 28, 2023
Active status
No
Manufacturer
Manufacturer name
The Standard. Co., Ltd.
Country
Republic of Korea
Country type
NON_EU
Address
120 Gunpocheomdansaneop 2-ro 15880 Gunpo
Email
qm.thestd@gmail.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
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Finland
Market available
Finland:2021-08-06~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

LENS CLEANING UNITS

About this record

Access comprehensive regulatory information for Defogger Anti-fog System in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 08809380052577 and manufactured by The Standard. Co., Ltd. in Republic of Korea.

This page provides complete registration details including trade name (Defogger Anti-fog System), 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.