Identity
- Trade Name
- JAZZ EUDAMED
- Device Name
- Jazz EUDAMED
- Model / Reference
- JAZZ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649990295008 EUDAMED07649990295022 EUDAMED
- Basic UDI-DI
- 7649990295JAZZNJ EUDAMED
- Direct Marketing DI
- 07649990295008 EUDAMED07649990295022 EUDAMED
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands 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
Jazz by AI Medical AG — Class IIa — 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 | 7649990295JAZZNJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- AI Medical AG
- EUDAMED SRN
- CH-MF-000026860
- Authorised Representative
- MED-RAS GmbH Regulatory Affairs Service DE-AR-000006211
Sources (2)
- EUDAMED 93a17517-5f17-4f66-976f-5b81984a1b58 61 fields · synced Sep 18, 2026
- EUDAMED b32d0a43-7c48-421d-98f3-f4f2caf3b4b3 61 fields · synced May 17, 2026