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Shoocin FS050535

by Lepu Medical Technology (Beijing) Co., Ltd.

Ref FS050535Model FS series, No guidewire

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69367337LP0030MF Basic UDI-DI 06941785219543UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06941785219543 UDI-DI Date17 Sep 2025ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Shoocin™ EUDAMED
Shoocin GUDID
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Reference
FS050535, FS series, No guidewire
Primary DI / UDI-DI
06941785219543 EUDAMED
06941785291198 GUDID
Basic UDI-DI
69367337LP0030MF
FDA Product Code
DYB
EMDN Code
C01040280 Peripheral angiography devices - accessories not included in other classes
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1340
EU market of registration
Cyprus
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06941785219543
GUDID
06941785291198
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Lepu Medical Technology (Beijing) Co., Ltd.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No