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Renal dilator

by Aster Medispro Private Limited EUDAMED

Active European Union

Ref AMPL-CA-DL-011-R0Model Renal dilator 14Fr 40cm, Renal dilator 15Fr 30cm, Renal dilator 18Fr 30cm, Renal dilator 26Fr 40cm, Renal dilator 11Fr 40cm, Renal dilator 15Fr 40cm, Renal dilator 14Fr 30cm, Renal dilator 22Fr 30cm, Renal dilator 24Fr 40cm, Renal dilator 18Fr 40cm

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890413355702355 Basic UDI-DIDate11 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Renal dilator
Model / Reference
Renal dilator 14Fr 40cm, AMPL-CA-DL-011-R0, Renal dilator 15Fr 30cm, Renal dilator 18Fr 30cm, Renal dilator 26Fr 40cm, Renal dilator 11Fr 40cm, Renal dilator 15Fr 40cm, Renal dilator 14Fr 30cm, Renal dilator 22Fr 30cm, Renal dilator 24Fr 40cm, Renal dilator 18Fr 40cm
Primary DI / UDI-DI
89041335570230, 89041335570308, 89041335083532, 89041335571220, 89041335570094, 89041335570476, 89041335083396, 89041335083778, 89041335571152, 89041335570612
Basic UDI-DI
890413355702355, 890413355703052, 89041335083534D, 890413355712258, 89041335570095B, 89041335570475K, 89041335083394K, 89041335083774T, 89041335571155B, 89041335570615D
Direct Marketing DI
89041335570230
89041335570308
89041335083532
89041335571220
89041335570476
89041335083396
89041335083778
89041335571152
89041335570612
EMDN Code
U03010101 Amplatz cannulas for urinary dilation
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
IN-MF-000013179
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

Show 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