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SMARTRION Nd:YAG
EUDAMEDClass IIb (EU MDR)
Ref IDS-UM-0633Model SMARTRION Nd:YAG
by Ids Ltd.
Identity
- Trade Name
- SMARTRION Nd:YAG EUDAMED
- Device Name
- Long pulsed Nd:YAG Laser EUDAMED
- Model / Reference
- SMARTRION Nd:YAG EUDAMEDIDS-UM-0633 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809578390405 EUDAMED
- Basic UDI-DI
- B-08809578390405 EUDAMED
- EMDN Code
- Z12011012 DYE/ALEXANDRITE SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
SMARTRION Nd:YAG by Ids Ltd. — Class IIb — 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-08809578390405 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Ids Ltd.
- EUDAMED SRN
- KR-MF-000018259
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 8051d027-8253-4b47-bff0-cd8df5cecf73 61 fields · synced Jul 28, 2026