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Mono J Catheter & Set

by Blue Neem Medical Devices Private Limited India EUDAMED

Ref BMJB00507003

EMDN U020199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8905080BUCGW Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
BMJB00507003
Primary DI / UDI-DI
08905080008880
Basic UDI-DI
8905080BUCGW
EMDN Code
U020199 Ureteral catheters without balloon - other
Device Class
Class IIa
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IN-MF-000021793
Authorised representative
Arazy Group (Ireland) Ltd. IE-AR-000000093

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 3da8bc2b-58a6-4b3e-a179-1479768d4f40 61 fields · synced 23 Oct 2026