ALIB024EH
Ref ALIB024EHModel SGTi-Allergy Screen Inhalant Panel
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-08809408862959 08809408862959 | Date27 Aug 2026 | 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- Withdrawn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
- Model / Reference
- SGTi-Allergy Screen Inhalant Panel, ALIB024EH
- Primary DI / UDI-DI
- 08809408862959
- Basic UDI-DI
- B-08809408862959
- EMDN Code
- W01020205 Immunoglobulin e - screen
- Device Class
- Class IVD General
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000023952
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Sugentech, Inc.
Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No