Identity
- Device Name
- Medical Angiography X-ray System EUDAMED
- Model / Reference
- Vicor-CV SWIFT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974091370028 EUDAMED
- Basic UDI-DI
- 697409137VCV000N2 EUDAMED
- Direct Marketing DI
- 06974091370028 EUDAMED
- EMDN Code
- Z11030102 STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Bulgaria 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
Medical Angiography X-ray System by Lepu Medical Equipment (Beijing) Co., Ltd. — 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 | 697409137VCV000N2 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Lepu Medical Equipment (Beijing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000017314
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED 350738b6-0489-4ae4-a27e-9e015f06beba 61 fields · synced Jul 9, 2026