MEDIPHOT DLM - Dry Laser Mammography Imaging Film 20x25cm (8x10) - 150 sheets
by Colenta Labortechnik GmbH & Co KG
Ref 2010420105Model DLMFilm
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 | Number912010420DLMFilmAH 19120104201054 | Date23 Feb 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- Withdrawn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
- Trade Name
- MEDIPHOT DLM - Dry Laser Mammography Imaging Film 20x25cm (8"x10") - 150 sheets
- Model / Reference
- DLMFilm, 2010420105
- Primary DI / UDI-DI
- 19120104201054
- Basic UDI-DI
- 912010420DLMFilmAH
- Direct Marketing DI
- 19120104201054
- EMDN Code
- Z130107 Films for reproduction from laser technologies
- 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