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SkyLoach

by Skynor Medical（Shanghai）Co., Ltd 50 variants

Ref 07Model IB-3015

SkyLoach (07) is a Class III device made by Skynor Medical（Shanghai）Co., Ltd, registered in EUDAMED on 8 Aug 2023 (Basic UDI-DI B-06970757200432), active as of 22 Oct 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970757200432 Basic UDI-DI 06970757200432UDI-DIDate8 Aug 2023RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Intracranial Balloon Dilatation Catheter
Model / reference
IB-3015, 07
Primary DI / UDI-DI
06970757200432
Basic UDI-DI
B-06970757200432
EMDN code
C019010 Intravascular recanalisation systems
Device class
Class III
EU registration type
Legacy device (under a directive)
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000028227
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Related devices

Category: Vascular graft tunneller

Similar devices in this category

Other devices filed under INTRAVASCULAR RECANALISATION SYSTEMS.

Other devices from Skynor Medical（Shanghai）Co., Ltd

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Properties

  • Supplied sterile
Other properties (11, all answered No)