EUDAMED registration 08809369092594NoCross-linked Hyaluronate Acid Dermal Filler
- Risk class
- Class III
- CND nomenclatures code
- P900402
- Trade name
- FLORE
- Implantable
- Yes
- Reusable
- No
- Measuring function
- No
- Primary DI
- 08809369092594
- Basic UDI
- B-08809369092594
- Version date
- August 31, 2022
- Manufacturer last update
- February 10, 2023
- Active status
- No
- Manufacturer name
- BNC KOREA, Inc.
- Country
- Republic of Korea
- Country type
- NON_EU
- Address
- 62 Seongseogongdan-ro 11-gil Dalseo-gu, Daegu
- sales@bnckorea.co.kr
- Name
- JaviTech e.K.
- SRN
- DE-AR-000005875
- Country
- Germany
- Address
- 16 Sachsenhausener Str. Schwalbach am Taunus
- info@javitech.de
- Telephone
- +49 176 7298 9240
- Competent authority
- DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
- Applicable legislation
- MDD (Directive 93/42/EEC on Medical Devices)
- Placed on the market
- Germany
- Market available
- Cyprus:None~None, Germany:None~None, Sweden:None~None, Turkey:None~None
- Human tissues
- No
- Animal tissues
- No
RESORBABLE FILLING AND RECONSTRUCTION DEVICES
Access comprehensive regulatory information for Cross-linked Hyaluronate Acid Dermal Filler in the European Union medical device market through Pure Global AI's free database. This Class III device is registered with EU EUDAMED under Primary DI 08809369092594 and manufactured by BNC KOREA, Inc. in Republic of Korea.
This page provides complete registration details including trade name (FLORE), manufacturer information, authorized representative details, competent authority (DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt), 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.