TOXO Toxoplasma Antibody IgM/ IgG Rapid Test Kit (Colloidal Gold)
- Risk class
- IVD Annex II List B
- CND nomenclatures code
- W0105090499
- Trade name
- TOXO Toxoplasma Antibody IgM/ IgG Rapid Test Kit (Colloidal Gold)
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06935091671782
- Basic UDI
- B-06935091671782
- Version date
- February 17, 2025
- Manufacturer last update
- November 16, 2023
- Active status
- No
- Manufacturer name
- Qingdao Hightop Biotech Co., Ltd.
- Country
- China
- Country type
- NON_EU
- Address
- No.369 Hedong Road Qingdao, Shandong
- registered@hightopqd.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
- No
PARASITES - RT & POC - OTHER
Access comprehensive regulatory information for TOXO Toxoplasma Antibody IgM/ IgG Rapid Test Kit (Colloidal Gold) in the European Union medical device market through Pure Global AI's free database. This IVD Annex II List B device is registered with EU EUDAMED under Primary DI 06935091671782 and manufactured by Qingdao Hightop Biotech Co., Ltd. in China.
This page provides complete registration details including trade name (TOXO Toxoplasma Antibody IgM/ IgG Rapid Test Kit (Colloidal Gold)), 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.