Waterlase Laser Tips - Sapphire
Ref 7000692
Active
CE MDD
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/MDD | NumberB-00647529002933 00647529002933 | Date23 Feb 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- WL Laser Tips, C12-9, 2PK
- Model / Reference
- 7000692
- Primary DI / UDI-DI
- 00647529002933
- Basic UDI-DI
- B-00647529002933
- EMDN Code
- Z12011099 Laser surgery instruments - other
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000028587
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Biolase Mg LLC
Properties
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