Identity
- Trade Name
- qSuite, qXR, qER, qMSK, qCT EUDAMED
- Device Name
- qSuite EUDAMED
- Model / Reference
- qSuite EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860005118182 EUDAMED
- Basic UDI-DI
- 08600051181qER-NCCTTL EUDAMED
- Direct Marketing DI
- 00860005118182 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
qSuite, qXR, qER, qMSK, qCT 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 b3c8d7ed-79cf-4c4a-88eb-ad2d58018613 61 fields · synced Jun 19, 2026