ABO Set (Anti-A (1/512), Anti-B (1/512), Anti-D (1/128)), 3x10ml/Plastic Pack
Ref 8.02.47.0.0030, 8.02.53.1.0040
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-04260658555994 | Date30 Jun 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Trade Name
- ABO Set (Anti-A (1/512), Anti-B (1/512), Anti-D (1/128)), 3x10ml/Plastic PackABO Set (Anti-A (1/512), Anti-B (1/512), Anti-AB (1/512) Anti-D (1/128)), 4x10ml, 4vials/Plastic Pack
- Model / Reference
- 8.02.47.0.0030, 8.02.53.1.0040
- Primary DI / UDI-DI
- 04260658555994, 04260658555710
- Basic UDI-DI
- B-04260658555994, B-04260658555710
- EMDN Code
- W0103030199, W0103030901
- Device Class
- Class IVD Annex II List A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000029961
Other devices from Atlas Medical GmbH
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