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SkyGuard

by Skynor Medical（Shanghai）Co., Ltd 8 variants

Ref 06Model BGC-7-100, BGC-8-095M, BGC-9-090S, BGC-9-050S, BGC-6-105, BGC-6-050, BGC-9-050M, BGC-9-090M, BGC-8-050M, BGC-7-050, BGC-8-085S

Active European Union

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970757209459 Basic UDI-DI Date14 Aug 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Balloon Guide Catheter
Model / Reference
BGC-7-100, 06, BGC-8-095M, BGC-9-090S, BGC-9-050S, BGC-6-105, BGC-6-050, BGC-9-050M, BGC-9-090M, BGC-8-050M, BGC-7-050, BGC-8-085S
Primary DI / UDI-DI
06970757209459, 06970757209510, 06970757209565, 06970757209527, 06970757209428, 06970757209404, 06970757209534, 06970757209572, 06970757209473, 06970757209435, 06970757209480
Basic UDI-DI
B-06970757209459, B-06970757209510, B-06970757209565, B-06970757209527, B-06970757209428, B-06970757209404, B-06970757209534, B-06970757209572, B-06970757209473, B-06970757209435, B-06970757209480
EMDN Code
C01050299 Intravascular embolic protection catheters and systems - other
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

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

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

See all devices from Skynor Medical（Shanghai）Co., Ltd →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No