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SkySurfer
EUDAMEDClass III (EU MDR)
Ref 04Model DAC5-105Model DAC4-148Model DAC4-140Model DAC6-130Model DAC6-125Model DAC5-115Model DAC6-105Model DAC6-115Model DAC5-095
Identity
- Trade Name
- SkySurfer EUDAMED
- Device Name
- Distal Access Catheter EUDAMED
- Model / Reference
- DAC5-105 EUDAMED04 EUDAMEDDAC4-148 EUDAMEDDAC4-140 EUDAMEDDAC6-130 EUDAMEDDAC6-125 EUDAMEDDAC5-115 EUDAMEDDAC6-105 EUDAMEDDAC6-115 EUDAMEDDAC5-095 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970757203778 EUDAMED06970757203846 EUDAMED06970757203839 EUDAMED06970757203754 EUDAMED06970757203747 EUDAMED06970757203785 EUDAMED06970757203723 EUDAMED06970757203730 EUDAMED06970757203761 EUDAMED
- Basic UDI-DI
- B-06970757203778 EUDAMEDB-06970757203846 EUDAMEDB-06970757203839 EUDAMEDB-06970757203754 EUDAMEDB-06970757203747 EUDAMEDB-06970757203785 EUDAMEDB-06970757203723 EUDAMEDB-06970757203730 EUDAMEDB-06970757203761 EUDAMED
- EMDN Code
- C019002 EMBOLECTOMY CATHETERS 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
SkySurfer 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-06970757203778 | 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 (9)
- EUDAMED 23ff7df4-1824-49e0-baeb-9704e151cf09 61 fields · synced Oct 6, 2026
- EUDAMED d8092ce6-9027-4d70-8e2e-acb0c03f49ed 61 fields · synced May 16, 2026
- EUDAMED 15e54067-302a-4dc2-a6f4-819e35c2e1ee 61 fields · synced May 17, 2026
- EUDAMED c44cb4c3-ac32-4c41-a71b-9e0dba2cbbeb 61 fields · synced May 17, 2026
- EUDAMED 436879ad-b0e5-487a-be2f-e661ca34ff79 61 fields · synced May 17, 2026
- EUDAMED 6c80eaa4-1a25-447b-9cb2-6cf2cd4a2d0b 61 fields · synced May 17, 2026
- EUDAMED cc1faa54-13b7-46a1-9360-80bdbe82c460 61 fields · synced May 17, 2026
- EUDAMED c5a23dd8-490c-40e5-b121-7ecd2a7ecb51 61 fields · synced May 17, 2026
- EUDAMED cc63fe1b-fbdc-4013-9d7c-3683d65ee4e9 61 fields · synced May 17, 2026