Atlas
by Atlas Medical GmbH 40 variants
Ref 8.04.73.0.0020
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-04260658552283 04260658552283 | Date30 Apr 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- Atlas Rotavirus -Adenovirus Antigens Test Device, Stool Sample, Individually Pouched, 20 Tests/Box.
- Model / Reference
- 8.04.73.0.0020
- Primary DI / UDI-DI
- 04260658552283
- Basic UDI-DI
- B-04260658552283
- EMDN Code
- W0105070504 Gastrointestinal infections - multiplex na reagents
- Device Class
- Class IVD General
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000029961
Other devices from Atlas Medical GmbH
Properties
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