EUDAMED registration 08806102610541NoSterile Single-Use Syringes with needles
- Risk class
- Class IIa
- CND nomenclatures code
- A02010499
- Trade name
- KOVAX-SYRINGE
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 08806102610541
- Basic UDI
- 880610260001B7
- Version date
- December 09, 2022
- Manufacturer last update
- September 05, 2022
- Active status
- No
- Manufacturer name
- Korea Vaccine co., Ltd.
- Country
- Republic of Korea
- Country type
- NON_EU
- Address
- 426 Samii-daero, Jongno-gu Seoul
- kkh8798@koreavaccine.com
- SRN
- NL-AR-000000235
- Country
- Netherlands
- Address
- 7 Amerlandseweg Breukelen
- e.unk@certification-experts.com
- Telephone
- +31850073210
- Competent authority
- Ministerie van Volksgezondheid, Welzijn en Sport
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Human tissues
- No
- Animal tissues
- No
SYRINGES FOR INJECTOR, SINGLE-USE - OTHER
Access comprehensive regulatory information for Sterile Single-Use Syringes with needles in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 08806102610541 and manufactured by Korea Vaccine co., Ltd. in Republic of Korea.
This page provides complete registration details including trade name (KOVAX-SYRINGE), 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.