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YianCore

by Zhong Ke Yi An medical technology (Beijing)Co., Ltd 43 variants

Ref FPLD011-03Model YA-3515

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970568710281 Basic UDI-DI 06970568710281UDI-DIDate28 May 2026RegisteredStatusActive

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  • Withdrawn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
YianCore®Rapamycin-Eluting Coronary Stent System
Model / Reference
YA-3515, FPLD011-03
Primary DI / UDI-DI
06970568710281
Basic UDI-DI
B-06970568710281
EMDN Code
P070402010301 Coronary drug eluting stents (des) with polymers
Device Class
Class III
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000045341
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Zhong Ke Yi An medical technology (Beijing)Co., Ltd

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Properties

  • Sterile
  • Implantable
  • Incorporates Medicinal Product

Other properties (8)

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