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BM Ureteral Dilation Balloon Catheters

by Bonree Medical Co., Ltd. 18 variants

Ref 406 10 12 2Model 4x40 4x60 4x100 5x40 5x60 5x100 6x40 6x60 6x100 7x40 7x60 7x100 8x40 8x60 8x100 10x40 10x60 10x100

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 Number697209192UDBC40KD Basic UDI-DI 06972091927150UDI-DIDate3 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  • Withdrawn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
Ureteral Dilation Balloon Catheters
Model / Reference
4x40 4x60 4x100 5x40 5x60 5x100 6x40 6x60 6x100 7x40 7x60 7x100 8x40 8x60 8x100 10x40 10x60 10x100, 406 10 12 2
Primary DI / UDI-DI
06972091927150
Basic UDI-DI
697209192UDBC40KD
Direct Marketing DI
06972091927150
EMDN Code
U030202 Ureteral dilators, with balloon
Device Class
Class IIa
EU market of registration
Poland

Manufacturer details

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

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