Identity
- Trade Name
- Careverse FFR EUDAMED
- Model / Reference
- Careverse FFR EUDAMEDCKCZ3009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974183380218 EUDAMED
- Basic UDI-DI
- 6974183382aCON0025A EUDAMED
- EMDN Code
- Z11030692 COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
Careverse FFR by Yukun (Beijing) Technology Co., Ltd. — 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 | 6974183382aCON0025A | Class IIa | Active |
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Manufacturer
- Manufacturer
- Yukun (Beijing) Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000040386
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED 2e0dde6b-1a72-4941-a87c-2cb1ba3e3f42 61 fields · synced Jun 18, 2026