Head Lamp
- Risk class
- Class I
- CND nomenclatures code
- Z129004
- Trade name
- BiLumix® Gen. 2S
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 08800271100018
- Basic UDI
- 88002711KN-0005H
- Version date
- January 09, 2025
- Manufacturer last update
- October 11, 2024
- Active status
- Yes
- 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
- sales@choicetech.kr
- SRN
- DE-AR-000004974
- Country
- Germany
- Address
- 97 Alsstr. Mönchengladbach
- joe@europecert.eu
- Telephone
- +49 2161 990 88 31
- Competent authority
- DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Germany
- Human tissues
- No
- Animal tissues
- No
LIGHT SOURCES
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.