Identity
- Trade Name
- qER-NCCT EUDAMED
- Device Name
- qSuite EUDAMED
- Model / Reference
- v1.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860005118120 EUDAMED
- Basic UDI-DI
- 08600051181qER-NCCTTL EUDAMED
- Direct Marketing DI
- 00860005118120 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
qER-NCCT 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 5d66be5f-a6c9-4d3d-a65e-63cc4b2ff731 61 fields · synced Jul 27, 2026