HighCap Xp
by Colenta Labortechnik GmbH & Co KG
Ref HighCap XpModel DICOM Printer
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 | Number912010420DICOMPrinter6B 09120104200012 | Date13 Jan 2023 | 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- Withdrawn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
- Model / Reference
- DICOM Printer, HighCap Xp
- Primary DI / UDI-DI
- 09120104200012
- Basic UDI-DI
- 912010420DICOMPrinter6B
- EMDN Code
- Z130106 Dry thermal printer x-ray films
- Device Class
- Class I
- EU market of registration
- Bulgaria
Manufacturer details
- EUDAMED SRN
- AT-MF-000016797
Other devices from Colenta Labortechnik GmbH & Co KG
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