EUDAMED registration 06930317829961NoDynamiker Candida Mannan Assay (POCT Chemiluminescence)
- Risk class
- IVD General
- CND nomenclatures code
- W0105060302
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06930317829961
- Basic UDI
- B-06930317829961
- Version date
- November 21, 2023
- Manufacturer last update
- October 20, 2023
- Active status
- No
- Manufacturer name
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- Country
- China
- Country type
- NON_EU
- Address
- No.2 Building, Rongzhi Industry Park, No. 3667, Zhongbin Avenue Sino-Singapore Eco-city, TEDA Tianjin
- marketing@dynamiker.com
- Name
- Lotus NL B.V.
- SRN
- NL-AR-000000121
- Country
- Netherlands
- Address
- Koningin Julianaplein 10, 1e Verd The Hague
- peter@lotusnl.com
- Competent authority
- Ministerie van Volksgezondheid, Welzijn en Sport
- Applicable legislation
- IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
- Placed on the market
- Netherlands
- Human tissues
- No
- Animal tissues
- Yes
CANDIDA ALBICANS
Access comprehensive regulatory information for Dynamiker Candida Mannan Assay (POCT Chemiluminescence) in the European Union medical device market through Pure Global AI's free database. This IVD General device is registered with EU EUDAMED under Primary DI 06930317829961 and manufactured by Dynamiker Biotechnology (Tianjin) Co., Ltd. in China.
This page provides complete registration details including 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.