Identity
- Trade Name
- ISOgray EUDAMED
- Device Name
- ISOgray EUDAMED
- Model / Reference
- IS1001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B501ISOGRAY0403010 EUDAMED
- Basic UDI-DI
- B-+B501ISOGRAY0403010 EUDAMED
- EMDN Code
- Z11010401 RADIOTHERAPY TREATMENT PLANNING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- -1192 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
ISOgray by Dosisoft — 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-+B501ISOGRAY0403010 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Dosisoft
- EUDAMED SRN
- FR-MF-000014706
Sources (1)
- EUDAMED cb317912-339c-4133-a7b8-6bbd275feb04 61 fields · synced May 23, 2026