Identity
- Trade Name
- SkyFlow EUDAMED
- Device Name
- Thrombectomy Device EUDAMED
- Model / Reference
- TD-420 EUDAMED03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970757203020 EUDAMED
- Basic UDI-DI
- B-06970757203020 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
SkyFlow by Skynor Medical（Shanghai）Co., Ltd — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Vascular graft tunneller.
- SURGIPROS — SURGIPROS LLC · Class I
- SURGIPROS — SURGIPROS LLC · Class I
- EMBOTRAP II — Neuravi Limited · Class III
- SURGIPROS — SURGIPROS LLC · Class I
- Tunneler, Bullet, Spare-part entspricht 03-5360.KA — Geister Medizin Technik GmbH · Class I
- Screw Olive Tip Ø 6.0 mm Stainless Steel — SURTEX INSTRUMENTS LTD · Class I
- SURGIPROS — SURGIPROS LLC · Class I
- Martin Vascular Tunneling Set Complete Set with 3 Shafts, 2 Handles and 12 Tips in Storage Case Stainless Steel — SURTEX INSTRUMENTS LTD · Class I
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-06970757203020 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Skynor Medical（Shanghai）Co., Ltd
- EUDAMED SRN
- CN-MF-000028227
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED e12a1a44-eb60-4606-8ab2-bd0f27e62f2f 61 fields · synced Jun 19, 2026