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Head Lamp - EUDAMED Registration 08800271100018

Access comprehensive regulatory information for Head Lamp 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 08800271100018 and manufactured by ChoiceTech Co., Ltd. in Republic of Korea.

This page provides complete registration details including trade name (BiLumix® Gen. 2S), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Düsseldorf Dezernat 24), 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
08800271100018
Yes
Head Lamp
Trade Name: BiLumix® Gen. 2S
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Device Description (EMDN)

LIGHT SOURCES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z129004
Trade Name
BiLumix® Gen. 2S
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08800271100018
Basic UDI
88002711KN-0005H
Version Date
January 09, 2025
Manufacturer Last Update
October 11, 2024
Active Status
Yes
Manufacturer
Manufacturer Name
ChoiceTech Co., Ltd.
Country
Republic of Korea
Country Type
NON_EU
Address
A-1301-3, 184, Jungbu-daero, Giheung-gu, Yongin-si, Gyeonggi-do
Email
sales@choicetech.kr
Authorized Representative
SRN
DE-AR-000004974
Country
Germany
Address
97 Alsstr. Mönchengladbach
Email
joe@europecert.eu
Telephone
+49 2161 990 88 31
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No