Atlas
by Atlas Medical GmbH Germany EUDAMED
Ref 8.04.21.0.0020 EMDN W0105010402
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-04260658551811 | Date30 Apr 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- H.pylori Antibody Test Device, Serum/Plasma, Individually Pouched, 20 Tests/Box
- Model / Reference
- 8.04.21.0.0020
- Primary DI / UDI-DI
- 04260658551811
- Basic UDI-DI
- B-04260658551811
- EMDN Code
- W0105010402 H. pylori antibody assays
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000029961
Other devices from Atlas Medical GmbH
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 4b34aa2e-66ff-4c9a-ae67-bec0dcfab8e5