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Ureteral Catheter U06A070812

by Well Lead Medical Co., Ltd

Ref U06A070812Model Open Tapered Tip

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

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 Number69449327FU06A07MK Basic UDI-DI 06936881158322UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06936881158322 UDI-DI Date6 Jan 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.

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  • Withdrawn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
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Ureteral Catheter
Generic Name
Ureteral catheter
Model / Reference
U06A070812, Open Tapered Tip
Primary DI / UDI-DI
06936881158322 EUDAMED
06936881157257 GUDID
Basic UDI-DI
69449327FU06A07MK
510(k) Number
FDA Product Code
KOD
EMDN Code
U020101 Ureteral catheters with cylindrical tip
GMDN Term
Ureteral catheter
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.5130
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06936881158322
GUDID
06936881157257
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K220036)

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Other devices from Well Lead Medical Co., Ltd

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Properties

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

Other properties (18)

  • 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