Identity
- Trade Name
- SkyLoach EUDAMED
- Device Name
- Intracranial Balloon Dilatation Catheter EUDAMED
- Model / Reference
- IB-3015 EUDAMED07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970757200432 EUDAMED
- Basic UDI-DI
- B-06970757200432 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-06970757200432 | 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 (1)
- EUDAMED 888575a0-ab58-4ba6-84e9-3ba295949572 61 fields · synced Jun 19, 2026