Pulse™
Ref M0068C06902
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number01915060000000000000601MY 00840456400142 | Date15 Sep 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Pulse 120H
- Model / Reference
- M0068C06902
- Primary DI / UDI-DI
- 00840456400142
- Basic UDI-DI
- 01915060000000000000601MY
- EMDN Code
- Z12011003 Holmium surgical laser
- Device Class
- Class IIb
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- IL-MF-000016033
- Authorised representative
- Boston Scientific Limited IE-AR-000003840
Other devices from Lumenis 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