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Disposable Ureteral Access Sheath

by Zhejiang YiGao Medical Technology Co., Ltd. 19 variants

Ref YGE-AGS11045, YGE-AGS11055, YGE-AGS11535, YGE-AGS11028, YGE-AGS14055, YGE-AGS10513, YGE-AGS11545, YGE-AGS09528, YGE-AGS14035, YGE-AGS13055, YGE-AGS11555, YGE-AGS13035, YGE-AGS12028, YGE-AGS12013, YGE-AGS09045, YGE-AGS09513, YGE-AGS13020, YGE-AGS10555, YGE-AGS11520, YGE-AGS10020, YGE-AGS10545, YGE-AGS12020, YGE-AGS09520, YGE-AGS11513, YGE-AGS13028, YGE-AGS09013, YGE-AGS14028, YGE-AGS14045, YGE-AGS11013, YGE-AGS10028, YGE-AGS12035, YGE-AGS12045, YGE-AGS09535, YGE-AGS09545510(k) K250132

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250132↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK250132 Date5 Sep 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number69368888AGS001V4 Basic UDI-DI Date14 Jul 2024RegisteredStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Model / Reference
YGE-AGS11045, YGE-AGS11055, YGE-AGS11535, YGE-AGS11028, YGE-AGS14055, YGE-AGS10513, YGE-AGS11545, YGE-AGS09528, YGE-AGS14035, YGE-AGS13055, YGE-AGS11555, YGE-AGS13035, YGE-AGS12028, YGE-AGS12013, YGE-AGS09045, YGE-AGS09513, YGE-AGS13020, YGE-AGS10555, YGE-AGS11520, YGE-AGS10020, YGE-AGS10545, YGE-AGS12020, YGE-AGS09520, YGE-AGS11513, YGE-AGS13028, YGE-AGS09013, YGE-AGS14028, YGE-AGS14045, YGE-AGS11013, YGE-AGS10028, YGE-AGS12035, YGE-AGS12045, YGE-AGS09535, YGE-AGS09545
Primary DI / UDI-DI
06923347298722, 06923347298739, 06923347298777, 06923347298708, 06923347298951, 06923347298623, 06923347298784, 06923347298517, 06923347298937, 06923347298906, 06923347298791, 06923347298883, 06923347298821, 06923347298807, 06923347298470, 06923347298494, 06923347298869, 06923347298678, 06923347298753, 06923347298579, 06923347298661, 06923347298814, 06923347298500, 06923347298746, 06923347298876, 06923347298432, 06923347298920, 06923347298944, 06923347298685, 06923347298586, 06923347298838, 06923347298845, 06923347298524, 06923347298531
Basic UDI-DI
69368888AGS001V4
EMDN Code
U090399 Single-use instruments for urogenital endoscopy - other
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000032913
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Zhejiang Yigao Medical Technology Co., Ltd.

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Properties

  • Sterile

Other properties (12)

  • 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