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Bm Hydrophilic Nelaton Catheters

by Bonree Medical Co., Ltd. 13 variants

Ref 31212002Model Super lubricath catheter:Male,40cm，6Fr，8Fr，10Fr，12Fr，14Fr，16Fr，18Fr，20Fr，22Fr；Female,20cm,6Fr，8Fr，10Fr，12Fr，14Fr，16Fr，18Fr，20Fr，22Fr

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 Number697209192NLTL23QM Basic UDI-DI 06942382611891UDI-DIDate22 May 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  • Withdrawn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
Nelaton Catheters
Model / Reference
Super lubricath catheter:Male, 40cm，6Fr，8Fr，10Fr，12Fr，14Fr，16Fr，18Fr，20Fr，22Fr；Female, 20cm, 6Fr，8Fr，10Fr，12Fr，14Fr，16Fr，18Fr，20Fr，22Fr, 31212002
Primary DI / UDI-DI
06942382611891
Basic UDI-DI
697209192NLTL23QM
Direct Marketing DI
06942382611891
EMDN Code
U01010501 Nelaton catheters, self-lubricating
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000017844
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use

Other devices from Bonree Medical Co., Ltd.

See all devices from Bonree Medical 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