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Semicircle type(Zoom handpiece)
EUDAMEDClass IIb (EU MDR)
Ref HOLLYWOOD SPECTRA
Identity
- Trade Name
- Semicircle type(Zoom handpiece) EUDAMED
- Device Name
- Frequency Doubled Q-switched Nd-YAG Laser system EUDAMED
- Model / Reference
- HOLLYWOOD SPECTRA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809447656311 EUDAMED
- Basic UDI-DI
- 88094476510118AVX EUDAMED
- EMDN Code
- Z12011017 NEODYMIUM SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands 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
Semicircle type(Zoom handpiece) by Lutronic Corporation — 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 | 88094476510118AVX | Class IIb | Active |
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Manufacturer
- Manufacturer
- Lutronic Corporation
- EUDAMED SRN
- KR-MF-000009035
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 51a0c5de-fd16-428b-b6e3-77058e0a9ee5 61 fields · synced Jul 11, 2026