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Sterile Nelaton Catheter

by Multigate Co., Ltd 39 variants

Ref UR046002Model 6Fr、8Fr、10Fr、12Fr、14Fr、16Fr、18Fr、20Fr

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697201396MU2ASNNNSNC001MX Basic UDI-DI 09341601003597UDI-DIDate1 Sep 2023RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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

Model / Reference
6Fr、8Fr、10Fr、12Fr、14Fr、16Fr、18Fr、20Fr, UR046002
Primary DI / UDI-DI
09341601003597
Basic UDI-DI
697201396MU2ASNNNSNC001MX
EMDN Code
U01010502 Nelaton catheters, non self-lubricating
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
CN-MF-000002513
Authorised representative
RFX+Care International A/S DK-AR-000001768

Other devices from Multigate Co., Ltd

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