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Amplatz Sheath

by Aster Medispro Private Limited India EUDAMED

Ref AMPL-CA-GP-001-R0Model Amplatz Sheath 32 Fr (For Dilator 28 Fr) 17 cm

EMDN U03010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89041335451814X Basic UDI-DIDate11 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Amplatz Sheath
Model / Reference
Amplatz Sheath 32 Fr (For Dilator 28 Fr) 17 cm, AMPL-CA-GP-001-R0
Primary DI / UDI-DI
89041335451812
Basic UDI-DI
89041335451814X
Direct Marketing DI
89041335451812
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

Other devices from Aster Medispro Private Limited

See all devices from Aster Medispro Private Limited →

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 c7103653-eafe-4fc8-8a5e-a317de3048a3 61 fields · synced 22 Oct 2026