Dengue NS1 Antigen Test Kit
by Anhui Deepblue Medical Technology Co., Ltd EUDAMED
Active
Ref DENN1W-1Model Cassette
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06952062772903 | Date14 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- Cassette, DENN1W-1
- Primary DI / UDI-DI
- 06952062772903
- Basic UDI-DI
- B-06952062772903
- EMDN Code
- W0105099007 Dengue - rt & poc
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000018785
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Other devices from Anhui Deepblue Medical Technology Co., Ltd
See all devices from Anhui Deepblue Medical Technology Co., Ltd →
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No