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Advanced Imaging Toolkit
EUDAMEDClass IIb (EU MDR)
Ref Advanced Imaging Toolkit v1.x
Identity
- Device Name
- Advanced Imaging Toolkit EUDAMED
- Model / Reference
- Advanced Imaging Toolkit v1.x EUDAMED
Identifiers
- Primary DI / UDI-DI
- *+B761RAPIDAIT01* EUDAMED
- Basic UDI-DI
- ++B761ADVIMAGINGTLKTUL EUDAMED
- Direct Marketing DI
- *+B761RAPIDAIT01* 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
- 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Advanced Imaging Toolkit by iSchemaView, Inc. — 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 | ++B761ADVIMAGINGTLKTUL | Class IIb | Active |
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Manufacturer
- Manufacturer
- iSchemaView, Inc.
- EUDAMED SRN
- US-MF-000040716
- Authorised Representative
- TSQ Global Srl IT-AR-000008109
Sources (1)
- EUDAMED 480957cc-1e94-49d5-9b27-96455f91dd0b 61 fields · synced Sep 17, 2026