Identity
- Trade Name
- DualMode® - Er: YAG 2940 nm EUDAMED
- Device Name
- DualMode® - Er: YAG 2940 nm EUDAMED
- Model / Reference
- 18091 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898961835303 EUDAMED
- Basic UDI-DI
- B-07898961835303 EUDAMED
- EMDN Code
- Z12040299 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
DualMode® - Er: YAG 2940 nm by Vydence Medical – Indústria e Comércio Ltda — 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-07898961835303 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Vydence Medical – Indústria e Comércio Ltda
- EUDAMED SRN
- BR-MF-000041042
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED a67d7e09-a955-45b8-aa8b-6ebba88d70c9 61 fields · synced Oct 6, 2026