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Angioway™
EUDAMEDClass IIa (EU MDR)
Ref MK-018Model stopcock indicates OFF, 30/60/90/120 cm extension tube
Identity
- Trade Name
- Angioway™ EUDAMED
- Device Name
- Contrast Medium Injection Manifold Kit EUDAMED
- Model / Reference
- stopcock indicates OFF, 30/60/90/120 cm extension tube EUDAMEDMK-018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936733775035 EUDAMED
- Basic UDI-DI
- 69367337LP0019MT EUDAMED
- EMDN Code
- C010480 ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Vascular guidewire introduction sleeve
Angioway™ by Lepu Medical Technology (Beijing) Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Vascular guidewire introduction sleeve.
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- Y Connector Pack — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
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 | 69367337LP0019MT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lepu Medical Technology (Beijing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001408
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED f4bc324e-20d1-41d0-8777-cae4992925e6 61 fields · synced May 22, 2026