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SkyLoach
EUDAMEDClass III (EU MDR)
Ref 07Model IB-2712Model IB-2706Model IB-2020Model IB-2025Model IB-2515Model IB-3025Model IB-4010Model IB-2715Model IB-2225Model IB-3220Model IB-3012Model IB-2206Model IB-2220Model IB-3210Model IB-3010Model IB-3006Model IB-3215Model IB-3525Model IB-2525Model IB-1506Model IB-1510Model IB-1515Model IB-2720Model IB-2010Model IB-4012Model IB-2215Model IB-2725Model IB-2520Model IB-3520Model IB-3512
Identity
- Trade Name
- SkyLoach EUDAMED
- Device Name
- Intracranial Balloon Dilatation Catheter EUDAMED
- Model / Reference
- IB-2712 EUDAMED07 EUDAMEDIB-2706 EUDAMEDIB-2020 EUDAMEDIB-2025 EUDAMEDIB-2515 EUDAMEDIB-3025 EUDAMEDIB-4010 EUDAMEDIB-2715 EUDAMEDIB-2225 EUDAMEDIB-3220 EUDAMEDIB-3012 EUDAMEDIB-2206 EUDAMEDIB-2220 EUDAMEDIB-3210 EUDAMEDIB-3010 EUDAMEDIB-3006 EUDAMEDIB-3215 EUDAMEDIB-3525 EUDAMEDIB-2525 EUDAMEDIB-1506 EUDAMEDIB-1510 EUDAMEDIB-1515 EUDAMEDIB-2720 EUDAMEDIB-2010 EUDAMEDIB-4012 EUDAMEDIB-2215 EUDAMEDIB-2725 EUDAMEDIB-2520 EUDAMEDIB-3520 EUDAMEDIB-3512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970757200364 EUDAMED06970757200340 EUDAMED06970757200104 EUDAMED06970757200111 EUDAMED06970757200319 EUDAMED06970757200456 EUDAMED06970757200562 EUDAMED06970757200371 EUDAMED06970757200173 EUDAMED06970757200494 EUDAMED06970757200425 EUDAMED06970757200128 EUDAMED06970757200166 EUDAMED06970757200463 EUDAMED06970757200418 EUDAMED06970757200401 EUDAMED06970757200487 EUDAMED06970757200555 EUDAMED06970757200333 EUDAMED06970757200012 EUDAMED06970757200029 EUDAMED06970757200043 EUDAMED06970757200388 EUDAMED06970757200074 EUDAMED06970757200579 EUDAMED06970757200159 EUDAMED06970757200395 EUDAMED06970757200326 EUDAMED06970757200548 EUDAMED06970757200524 EUDAMED
- Basic UDI-DI
- B-06970757200364 EUDAMEDB-06970757200340 EUDAMEDB-06970757200104 EUDAMEDB-06970757200111 EUDAMEDB-06970757200319 EUDAMEDB-06970757200456 EUDAMEDB-06970757200562 EUDAMEDB-06970757200371 EUDAMEDB-06970757200173 EUDAMEDB-06970757200494 EUDAMEDB-06970757200425 EUDAMEDB-06970757200128 EUDAMEDB-06970757200166 EUDAMEDB-06970757200463 EUDAMEDB-06970757200418 EUDAMEDB-06970757200401 EUDAMEDB-06970757200487 EUDAMEDB-06970757200555 EUDAMEDB-06970757200333 EUDAMEDB-06970757200012 EUDAMEDB-06970757200029 EUDAMEDB-06970757200043 EUDAMEDB-06970757200388 EUDAMEDB-06970757200074 EUDAMEDB-06970757200579 EUDAMEDB-06970757200159 EUDAMEDB-06970757200395 EUDAMEDB-06970757200326 EUDAMEDB-06970757200548 EUDAMEDB-06970757200524 EUDAMED
- EMDN Code
- C019010 INTRAVASCULAR RECANALISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Vascular graft tunneller
SkyLoach by Skynor Medical（Shanghai）Co., Ltd — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970757200364 | Class III | Active |
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Manufacturer
- Manufacturer
- Skynor Medical（Shanghai）Co., Ltd
- EUDAMED SRN
- CN-MF-000028227
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (30)
- EUDAMED 80714b7e-ff4a-4f6e-b956-1459583a0833 61 fields · synced Sep 30, 2026
- EUDAMED d239505d-5711-4bfd-87d0-4b0fd5dc266d 61 fields · synced May 11, 2026
- EUDAMED c664a9e5-6a03-417d-b74b-5e9f05c0819a 61 fields · synced May 16, 2026
- EUDAMED cbbbcb6c-f6ef-493d-a298-cfc946a0ee9f 61 fields · synced May 16, 2026
- EUDAMED 6f7e0b6d-89d0-42ab-b3fc-a7eb44772402 61 fields · synced May 17, 2026
- EUDAMED 67be364c-623f-42a5-836e-2a1c9c6dabb7 61 fields · synced May 17, 2026
- EUDAMED be34bad6-aba3-42e9-bb0c-832145a5f0e7 61 fields · synced May 17, 2026
- EUDAMED 8df459bc-5edf-419c-97db-0122a83170e8 61 fields · synced May 17, 2026
- EUDAMED aed0f825-b44e-45bc-a7cb-90f1fc8248ee 61 fields · synced May 17, 2026
- EUDAMED 8b3ae931-6a0c-44f7-b308-118e5727d8fe 61 fields · synced May 17, 2026
- EUDAMED a43716e9-62b4-484c-87bf-f2870f1936d7 61 fields · synced May 17, 2026
- EUDAMED ad78d8d8-dd58-4f9f-b65f-0f3d38d87270 61 fields · synced May 17, 2026
- EUDAMED 0e6a570f-f9c6-4ba7-a190-ef748f53a47a 61 fields · synced May 17, 2026
- EUDAMED b27130de-9e12-4e1a-bccb-ea21b20ff994 61 fields · synced May 17, 2026
- EUDAMED ec76b80a-0186-449e-bbb0-1b67075d918b 61 fields · synced May 17, 2026
- EUDAMED 298a08a8-007a-45ad-87fa-b675922ec30b 61 fields · synced May 19, 2026
- EUDAMED c42b9392-12ca-4308-a8a5-d647126e5e09 61 fields · synced May 19, 2026
- EUDAMED 68bb179c-e136-4499-8e35-c10a65e866d7 61 fields · synced May 19, 2026
- EUDAMED ca57b349-e286-4f92-bd91-736b1d25cd02 61 fields · synced May 19, 2026
- EUDAMED c39375a6-a982-473c-a611-0c42fb1fad6e 61 fields · synced May 19, 2026
- EUDAMED 4349a72a-48f6-4840-9d10-c02c453e675c 61 fields · synced May 19, 2026
- EUDAMED fe6c0fae-f18f-49db-9371-e87a8a67a045 61 fields · synced May 19, 2026
- EUDAMED 9f1ce389-f589-4b3c-b05c-48425c5635b9 61 fields · synced May 19, 2026
- EUDAMED f28a5ed7-dcbc-4a2b-8904-c29064e52724 61 fields · synced May 19, 2026
- EUDAMED b825a46f-9872-47a7-8f62-d24ea849aa70 61 fields · synced May 19, 2026
- EUDAMED 52ae19ec-adb9-4613-a72c-65b535d1dbaa 61 fields · synced May 19, 2026
- EUDAMED cc3fae2f-b142-401e-af39-3737b6daed64 61 fields · synced May 19, 2026
- EUDAMED 4a9c5a99-2b25-4643-86a2-26fb493dff67 61 fields · synced May 19, 2026
- EUDAMED bcbbe6f5-ba42-40a6-a34d-326f8f4dc914 61 fields · synced May 19, 2026
- EUDAMED c5245e31-3bdd-4fc8-87f1-7cf577a1be47 61 fields · synced May 19, 2026