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Semicircle type(8mm-Zoom-Collimated handpiece)
EUDAMEDClass IIb (EU MDR)
Ref HOLLYWOOD SPECTRA
Identity
- Trade Name
- Semicircle type(8mm-Zoom-Collimated handpiece) EUDAMED
- Device Name
- Frequency Doubled Q-switched Nd-YAG Laser system EUDAMED
- Model / Reference
- HOLLYWOOD SPECTRA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809447656328 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(8mm-Zoom-Collimated 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 Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88094476510118AVX | Class IIb | Unknown |
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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 a0bd43af-c983-4c10-b492-bcd411fbbf1d 61 fields · synced Jul 9, 2026