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Wellead Stone Retrieval Basket

by Well Lead Medical Co., Ltd. 7 variants

Ref U04B011010Model SB4NS-18090, SB4NS-18120, SB4NS-22120, SB4TL-25120, SB6NL-25120, SB3NS-17130-8, SB3NS-17130-11, SB4TL-30090, SB4NS-13120

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 Number69449327FU04B01LW Basic UDI-DI 06936881139383UDI-DIDate9 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06936881139383 UDI-DI Date12 Jul 2023ListedStatusListed 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  • Withdrawn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

Generic Name
Urinary stone retrieval basket, single-use
Device Name
Stone Retrieval Basket
Model / Reference
SB4NS-18090, SB4NS-18120, SB4NS-22120, SB4TL-25120, SB6NL-25120, SB3NS-17130-8, SB3NS-17130-11, SB4TL-30090, SB4NS-13120, U04B011010
Primary DI / UDI-DI
06936881139383
Basic UDI-DI
69449327FU04B01LW
FDA Product Code
FFL
EMDN Code
U090101 Urinary stone retrieval baskets
GMDN Term
Urinary stone retrieval basket, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.4680
Market of Registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000006728
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Well Lead Medical Co., Ltd

See all devices from Well Lead Medical Co., Ltd →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Serial Number: No