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Frequency Doubled Q-switched Nd-YAG Laser
EUDAMEDClass IIb (EU MDR)
Ref PICOPLUSRef SPECTRA XT
Identity
- Device Name
- Frequency Doubled Q-switched Nd-YAG Laser EUDAMED
- Model / Reference
- PICOPLUS EUDAMEDSPECTRA XT EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-10115EB EUDAMEDD-10106EA EUDAMED
- Basic UDI-DI
- B-10115EB EUDAMEDB-10106EA EUDAMED
- EMDN Code
- Z12011017 NEODYMIUM SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMEDBelgium 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
Frequency Doubled Q-switched Nd-YAG Laser by Lutronic Corporation — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10115EB | 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 (2)
- EUDAMED 65fb45de-4d45-48ef-9819-1d4034957fb9 61 fields · synced Jul 30, 2026
- EUDAMED b0817ddc-a443-4a96-96fe-9d87d2ac0ecd 61 fields · synced Jul 30, 2026