Identity
- Trade Name
- Laser Handpiece EUDAMED
- Device Name
- Whitening Handpiece EUDAMEDTurbo Handpiece EUDAMED
- Model / Reference
- 7400022 EUDAMED6201126 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00647529003725 EUDAMED00647529003961 EUDAMED
- Basic UDI-DI
- B-00647529003725 EUDAMEDB-00647529003961 EUDAMED
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Laser Handpiece by Biolase Mg Llc — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00647529003725 | Class I | Active |
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Manufacturer
- Manufacturer
- Biolase Mg Llc
- EUDAMED SRN
- US-MF-000028587
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED f439e3d3-b3f1-4008-8c95-634fc63ce135 61 fields · synced Sep 30, 2026
- EUDAMED c31784f5-e5ee-4ae1-9165-290c0d6ff993 61 fields · synced May 19, 2026