INNO Sub. Abutment
- Risk class
- Class IIb
- CND nomenclatures code
- P01020101
- Trade name
- INNO Implant System
- Implantable
- Yes
- Reusable
- No
- Measuring function
- No
- Primary DI
- 08800016105070
- Basic UDI
- B-08800016105070
- Version date
- August 06, 2024
- Manufacturer last update
- May 20, 2024
- Active status
- No
- Manufacturer name
- Cowellmedi Co., Ltd.
- Country
- Republic of Korea
- Country type
- NON_EU
- Address
- 48 Hakgam-daero 221beon-gil Busan
- osj@cowellmedi.co.kr
- Name
- AR Experts B.V.
- SRN
- NL-AR-000023989
- Country
- Netherlands
- Address
- 7 Amerlandseweg Breukelen
- info@ar-experts.eu
- Telephone
- +31889951333
- Competent authority
- Ministerie van Volksgezondheid, Welzijn en Sport
- Applicable legislation
- MDD (Directive 93/42/EEC on Medical Devices)
- Placed on the market
- Netherlands
- Market available
- Netherlands:2024-01-01~None
- Human tissues
- No
- Animal tissues
- No
DENTAL IMPLANTS
Access comprehensive regulatory information for INNO Sub. Abutment in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 08800016105070 and manufactured by Cowellmedi Co., Ltd. in Republic of Korea.
This page provides complete registration details including trade name (INNO Implant 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.