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AI-Rad Companion Prostate MR
EUDAMEDClass IIb (EU MDR)
Ref 11582981Model MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_MR-P
Identity
- Trade Name
- AI-Rad Companion Prostate MR EUDAMED
- Device Name
- MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_MR-P EUDAMED
- Model / Reference
- MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_MR-P EUDAMED11582981 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869298191 EUDAMED
- Basic UDI-DI
- 0405686902009V3 EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software 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
AI-Rad Companion Prostate MR by Siemens Healthcare GmbH — Class IIb — CE/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 | 0405686902009V3 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
- EUDAMED SRN
- DE-MF-000006122
Sources (1)
- EUDAMED 8ee93698-6d01-4cf6-adfd-d7ca9fd5e4a6 61 fields · synced Oct 7, 2026