Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit
- Risk class
- IVD General
- CND nomenclatures code
- W0105090401
- Trade name
- Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- D-SC20202W-25TWD
- Basic UDI
- B-SC20202W-25TWD
- Version date
- August 14, 2023
- Manufacturer last update
- August 03, 2023
- Active status
- No
- Manufacturer name
- Jiangsu Bioperfectus Technologies Co., Ltd.
- Country
- China
- Country type
- NON_EU
- Address
- No. 837, Yaocheng Avenue, 225300 Taizhou City, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA. Taizhou,Jiangsu
- support@bioperfectus.com
- SRN
- DE-AR-000000002
- Country
- Germany
- Address
- 10 Borkstrasse Münster
- ecrep@medneteurope.com
- Telephone
- +49 251 322 66 64
- Competent authority
- DE/CA22 - Bezirksregierung Münster
- Applicable legislation
- IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
- Placed on the market
- Germany
- Human tissues
- No
- Animal tissues
- Yes
PLASMODIUM (MALARIA) - RT & POC
Access comprehensive regulatory information for Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit 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 D-SC20202W-25TWD and manufactured by Jiangsu Bioperfectus Technologies Co., Ltd. in China.
This page provides complete registration details including trade name (Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit), manufacturer information, authorized representative details, competent authority (DE/CA22 - Bezirksregierung Münster), 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.