HBA1C 2R
by Erba Lachema s.r.o. Czech Republic EUDAMED
Ref XSYS0096
EMDN W0102060109
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number8592156ICRE0109WS | Date7 Oct 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- XSYS0096
- Primary DI / UDI-DI
- 08592156151696
- Basic UDI-DI
- 8592156ICRE0109WS
- EMDN Code
- W0102060109 Glycosylated/glycated haemoglobin (ic)
- Device Class
- Class C
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000024067
Other devices from Erba Lachema s.r.o.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 08592156151696|8592156ICRE0109WS