Identity
- Trade Name
- SkyGuard EUDAMED
- Device Name
- Balloon Guide Catheter EUDAMED
- Model / Reference
- BGC-9-085S EUDAMED06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970757209541 EUDAMED
- Basic UDI-DI
- B-06970757209541 EUDAMED
- EMDN Code
- C01050299 INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER 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
SkyGuard by Skynor Medical（Shanghai）Co., Ltd — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06970757209541 | 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 a2957d30-867e-4fb5-b77b-cdd5e5c9aace 61 fields · synced Jun 19, 2026