Identity
- Trade Name
- DRF 4343-LT EUDAMED
- Model / Reference
- HIRIS TSI EUDAMEDSI 11 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055186671201 EUDAMED
- Basic UDI-DI
- 805518667HIRISTSIEW EUDAMED
- EMDN Code
- Z11031192 SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy 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
Drf 4343-Lt by A.T.S. Applicazione Tecnologie Speciali s.r.l. — Class IIb — 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 | 805518667HIRISTSIEW | Class IIb | Active |
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Manufacturer
- Manufacturer
- A.T.S. Applicazione Tecnologie Speciali s.r.l.
- EUDAMED SRN
- IT-MF-000010734
Sources (1)
- EUDAMED 2f56fe77-815b-40cd-a90a-4caef1301c3d 61 fields · synced Oct 6, 2026