Prime|one
by Akzenta International SA 58 variants
Ref MICAP25-AKZ-MC-FNE
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number42504766MICUL 04250476618308 | Date15 Apr 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- Withdrawn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/MDR Active
Specification
- Device Name
- Micro Applicators
- Model / Reference
- MICAP25-AKZ-MC-FNE
- Primary DI / UDI-DI
- 04250476618308
- Basic UDI-DI
- 42504766MICUL
- EMDN Code
- Q019006 Dental material application tips and brushes, single-use
- Device Class
- Class I
- EU 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
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