Derm
by Skin Analytics Ltd. 4 variants
Ref DERM v5.1Model Deep Ensemble for Recognition of Malignancy (DERM) V4
Active
CE MDR
Valid until
18 Dec 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberSCAR-2.2.1.4 | Date10 Jun 2026 | StatusActive |
Certificates
- SCAR-2.2.1.4 Active
Quality management system EU MDR
- Certifier
- Scarlet NB B.V. 3022
- Issued
- 10 Jun 2026
- Expires
- 18 Dec 2029
- Reason
- Change approved
- SCAR-2.3.1.4 Active
Technical documentation EU MDR
- Certifier
- Scarlet NB B.V. 3022
- Issued
- 10 Jun 2026
- Expires
- 18 Dec 2029
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Deep Ensemble for Recognition of Malignancy (DERM) V4, DERM v5.1
- Primary DI / UDI-DI
- 05060717730084
- Basic UDI-DI
- 506071773DERM-DX-CEMDRXU
- EMDN Code
- Z12040192 General medicine diagnosis and monitoring instruments - medical device software
- Device Class
- Class III
- Special Device Type
- Software
- EU market of registration
- Lithuania
Manufacturer details
- EUDAMED SRN
- GB-MF-000017972
- Authorised representative
- Advena Limited MT-AR-000000234
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