Aqufill Hard
- Risk class
- Class III
- CND nomenclatures code
- P900402
- Trade name
- Aqufill Hard
- Implantable
- Yes
- Reusable
- No
- Measuring function
- No
- Primary DI
- 08809639786420
- Basic UDI
- B-08809639786420
- Version date
- February 13, 2024
- Manufacturer last update
- September 25, 2023
- Active status
- No
- Manufacturer name
- BioPlus Co., Ltd.
- Country
- Republic of Korea
- Country type
- NON_EU
- Address
- 14 Sagimakgol-ro 45beon-gil Seongnam-si
- info@ubioplus.com
- Name
- KTR Europe GmbH
- SRN
- DE-AR-000005685
- Country
- Germany
- Address
- 77 Mergenthalerallee Eschborn
- ktreurope@ktreurope.de
- Telephone
- +49 6196 887 170
- 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
- Germany:None~None, Turkey:None~None
- Human tissues
- No
- Animal tissues
- No
RESORBABLE FILLING AND RECONSTRUCTION DEVICES
Access comprehensive regulatory information for Aqufill Hard 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 08809639786420 and manufactured by BioPlus Co., Ltd. in Republic of Korea.
This page provides complete registration details including trade name (Aqufill Hard), 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.