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Dream Oct
EUDAMEDClass IIa (EU MDR)
Ref VG100DModel VG100D, VG200D, VG S, VG200C
Identity
- Trade Name
- DREAM OCT EUDAMED
- Device Name
- DREAM OCT EUDAMED
- Model / Reference
- VG100D, VG200D, VG S, VG200C EUDAMEDVG100D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975480280003 EUDAMED
- Basic UDI-DI
- 697548028VG57 EUDAMED
- Direct Marketing DI
- 06975480280003 EUDAMED
- EMDN Code
- Z12120121 OPTICAL CONSISTENCY TOMOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Dream Oct by Intalight Group Co., Ltd. — Class IIa — 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 | 697548028VG57 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Intalight Group Co., Ltd.
- EUDAMED SRN
- CN-MF-000025982
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED c7748fd9-5489-4803-9f3d-8a195f928083 61 fields · synced Jun 19, 2026