Contact Plate Plain, OMNI 3000
Ref 808-560-07
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 | Number896110278DRMS808QC 08961102782411 | Date24 Nov 2025 | 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- Withdrawn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
- Dermatoscope
- Model / Reference
- 808-560-07
- Primary DI / UDI-DI
- 08961102782411
- Basic UDI-DI
- 896110278DRMS808QC
- EMDN Code
- Z12040108 Dermatoscopes
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- PK-MF-000021845
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Medical Devices (Pvt) Ltd
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