Dermatoscope
by Shenzhen Iboolo Optics Co., Ltd. China EUDAMED
Ref DE-4100 Pro, DE-500, DE-4100, DE-400, DE-3100 Pro, DE-5100, DE-6100, DE-200 EMDN Z12040108
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number692329904100PROXL | Date17 Apr 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Dermatoscope
- Model / Reference
- DE-4100 Pro, DE-500, DE-4100, DE-400, DE-3100 Pro, DE-5100, DE-6100, DE-200
- Primary DI / UDI-DI
- 06923299026657, 06923299000329, 06923299044347, 06923299013459, 06923299064505, 06923299036526, 06923299026886, 06923299032405
- Basic UDI-DI
- 692329904100PROXL, 69232990500UZ, 692329904100GM, 69232990400UU, 692329903100PROX3, 692329905100GU, 692329906100H3, 69232990200UJ
- EMDN Code
- Z12040108 Dermatoscopes
- Device Class
- Class I
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000029373
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Other devices from Shenzhen Iboolo Optics Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (8)
- EUDAMED 13af25bf-c1ed-47d4-94ac-73d9aed9ed80
- EUDAMED 06923299000329|69232990500UZ
- EUDAMED 06923299044347|692329904100GM
- EUDAMED 06923299013459|69232990400UU
- EUDAMED 06923299064505|692329903100PROX3
- EUDAMED 06923299036526|692329905100GU
- EUDAMED 06923299026886|692329906100H3
- EUDAMED 06923299032405|69232990200UJ