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Laser Handpiece
EUDAMEDClass IIb (EU MDR)
Ref MANTERAPEUTICOModel ZOOM TERMINAL 8mm-25mm
Identity
- Trade Name
- LASER HANDPIECE EUDAMED
- Model / Reference
- ZOOM TERMINAL 8mm-25mm EUDAMEDMANTERAPEUTICO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057949171942 EUDAMED
- Basic UDI-DI
- 805794917009ACLT3U EUDAMED
- Direct Marketing DI
- 08057949171942 EUDAMED
- EMDN Code
- Z120615 THERAPEUTIC LASERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Laser Handpiece by Fisioline Srl — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805794917009ACLT3U | Class IIb | Active |
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Manufacturer
- Manufacturer
- Fisioline Srl
- EUDAMED SRN
- IT-MF-000027924
Sources (1)
- EUDAMED e1cad1ba-a885-4f49-9a1e-8d02866ecdbc 61 fields · synced Jul 31, 2026