Identity
- Trade Name
- RadSmart EUDAMED
- Device Name
- RadSmart EUDAMED
- Model / Reference
- RadSmart EUDAMEDRadSmart Version 1.0.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908026312003 EUDAMED
- Basic UDI-DI
- 8908026312ED001V7 EUDAMED
- EMDN Code
- Z110603,Z11069092 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Malta 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
RadSmart by Endimension Technology Private Limited — Class I — 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 | 8908026312ED001V7 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Endimension Technology Private Limited
- EUDAMED SRN
- IN-MF-000046858
- Authorised Representative
- Specculo Limited MT-AR-000034988
Sources (1)
- EUDAMED b2a58426-915e-4ace-92ff-dd493c90a6ed 61 fields · synced Jun 18, 2026