Ultraformer Iii
by Classys South Korea EUDAMED
Ref UF3-M300
EMDN Z120610
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08800016900026 | Date16 Jun 2026 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Device Name
- Focused Ultrasound Therapeutic Equipment
- Model / Reference
- UF3-M300
- Primary DI / UDI-DI
- 08800016900026
- Basic UDI-DI
- B-08800016900026
- EMDN Code
- Z120610 Ultrasound therapy equipment
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000010116
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from CLASSYS Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 08800016900026|B-08800016900026