Identity
- Trade Name
- qXR EUDAMED
- Device Name
- qSuite EUDAMED
- Model / Reference
- v4.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860005118168 EUDAMED
- Basic UDI-DI
- 08600051181qER-NCCTTL EUDAMED
- Direct Marketing DI
- 00860005118168 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
- Austria 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
qXR by Qure.ai Technologies Private Limited — 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 | 08600051181qER-NCCTTL | Class IIb | Active |
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Manufacturer
- Manufacturer
- Qure.ai Technologies Private Limited
- EUDAMED SRN
- IN-MF-000018096
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 55e6ba06-77c8-41f0-a0b7-95009887c90d 61 fields · synced Jul 17, 2026