Identity
- Device Name
- Innersight3D EUDAMED
- Model / Reference
- 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05070002625308 EUDAMED
- Basic UDI-DI
- B-05070002625308 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Netherlands 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
Innersight3D by Innersight Labs Ltd — Class I — 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-05070002625308 | Class I | Active |
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Manufacturer
- Manufacturer
- Innersight Labs Ltd
- EUDAMED SRN
- UK-MF-000038155
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 89ae2d20-d241-45c6-82e9-c1ddfa692f42 61 fields · synced Jun 18, 2026