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Angioway™
EUDAMEDClass IIa (EU MDR)
Ref MK-007Model stopcock indicates ON, 30/60/90/120 cm extension tubeRef MK-019Model stopcock indicates OFF, 30/60/90/120 cm extension tubeRef MK-006Ref YNP50Model Push-pull connector, 20/25/40/50 cm extension tubingRef MK-017Ref YNP25Ref YNRModel Rotating connector, without extension tubingRef YNPModel Push-pull connector, without extension tubingRef MK-005Ref MK-020
Identity
- Trade Name
- Angioway™ EUDAMED
- Device Name
- Contrast Medium Injection Manifold Kit EUDAMEDY-Hemostasis Valve Set EUDAMED
- Model / Reference
- stopcock indicates ON, 30/60/90/120 cm extension tube EUDAMEDMK-007 EUDAMEDstopcock indicates OFF, 30/60/90/120 cm extension tube EUDAMEDMK-019 EUDAMEDMK-006 EUDAMEDPush-pull connector, 20/25/40/50 cm extension tubing EUDAMEDYNP50 EUDAMEDMK-017 EUDAMEDYNP25 EUDAMEDRotating connector, without extension tubing EUDAMEDYNR EUDAMEDPush-pull connector, without extension tubing EUDAMEDYNP EUDAMEDMK-005 EUDAMEDMK-020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936733775011 EUDAMED06936733775042 EUDAMED06936733775004 EUDAMED06936733775585 EUDAMED06936733775196 EUDAMED06936733775561 EUDAMED06936733775592 EUDAMED06936733775608 EUDAMED06936733775103 EUDAMED06936733775059 EUDAMED
- Basic UDI-DI
- 69367337LP0018MR EUDAMED69367337LP0019MT EUDAMED69367337LP0015MK EUDAMED69367337LP0017MP EUDAMED69367337LP0016MM EUDAMED
- EMDN Code
- C010480 ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMEDC900101 HAEMOSTASIS VALVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDEstonia EUDAMEDIceland EUDAMEDBulgaria EUDAMEDCzechia 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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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 | 69367337LP0018MR | 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 (10)
- EUDAMED 221eb80e-f5e4-4b95-8b62-634df94a45a1 61 fields · synced Jul 29, 2026
- EUDAMED c6c5c6fd-96b9-4dd7-837f-2ad8e8f5fd18 61 fields · synced May 16, 2026
- EUDAMED c0cc85a9-f70f-40c0-bf42-65b76b4394f8 61 fields · synced May 16, 2026
- EUDAMED 2fd1c963-5aee-4ce1-b9bd-790e467af6b1 61 fields · synced May 17, 2026
- EUDAMED 09b8b8af-2c7e-4040-8fb4-6aad7a1bfcfc 61 fields · synced May 17, 2026
- EUDAMED 234e9a01-d43a-49ba-a1db-1181e52f1c04 61 fields · synced May 17, 2026
- EUDAMED 79f8f2fb-42fb-4c6e-9c1a-90679666d61d 61 fields · synced May 18, 2026
- EUDAMED 7feef544-efa9-4643-a614-28d2f8e300ef 61 fields · synced May 18, 2026
- EUDAMED 6060136f-9f16-4924-9e67-0963167ffb3f 61 fields · synced May 19, 2026
- EUDAMED c06aa261-8275-4f32-ba5e-ed0554c6973c 61 fields · synced May 19, 2026