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Wellead Portable Roller Irrigation Pump

by Well Lead Medical Co., Ltd. 4 variants

Ref U10A010510Model WP-I-04

Active European Union

CE MDR

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/MDR Number69449327FU10A03LC Basic UDI-DI 26925816634745UDI-DIDate29 Jun 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Portable Roller Irrigation Pump
Model / Reference
WP-I-04, U10A010510
Primary DI / UDI-DI
26925816634745
Basic UDI-DI
69449327FU10A03LC
EMDN Code
A03010299 Irrigation controllers - other
Device Class
Class IIa
Medical Purpose
The Portable Roller Irrigation Pump is designed to infuse and irrigate body surface and cavity with sterile fluid with variable preset flow rates. It typically consists of electrically powered roller, flow rate control mechanism, and tubing (to accommodate various patient contact devices).

Manufacturer details

EUDAMED SRN
CN-PR-000053729

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

Properties

  • Sterile