Prime|one
by Akzenta International SA Switzerland EUDAMED
Ref INDEA26-AKZ-ST-UNI EMDN S0199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number42504766INDUH | Date26 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Chemical Indicator
- Model / Reference
- INDEA26-AKZ-ST-UNI
- Primary DI / UDI-DI
- 04250476626624
- Basic UDI-DI
- 42504766INDUH
- EMDN Code
- S0199 Devices for sterilisation and packaging (excluding cat. d - z) - other
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CH-MF-000036434
- Authorised representative
- IQX GmbH AT-AR-000016713
Other devices from Akzenta International SA
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 04250476626624|42504766INDUH