Identity
- Trade Name
- Diode Laser Tips - Pre Initiated Tips EUDAMED
- Device Name
- Diode Laser Tips, pre-initiated, Perio, 3-7, 30PK EUDAMED
- Model / Reference
- 7400064 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00647529003350 EUDAMED
- Basic UDI-DI
- B-00647529003350 EUDAMED
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Diode Laser Tips - Pre Initiated Tips by Biolase Mg Llc — Class IIa — 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-00647529003350 | Class IIa | 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 (1)
- EUDAMED 132882bc-2930-4094-9c7b-1d844ae8d197 61 fields · synced Jun 19, 2026