Skip to content

Amplatz Sheath

by Aster Medispro Private Limited India EUDAMED

Ref AMPL-CA-GP-001-R0Model Amplatz Sheath 24 Fr (For Dilator 20 Fr) 17 cm, Amplatz Sheath 32 Fr (For Dilator 28 Fr) 22 cm, Amplatz Sheath 34 Fr (For Dilator 30 Fr) 17 cm, Amplatz Sheath 26 Fr (For Dilator 22 Fr) 17 cm, Amplatz Sheath 16 Fr (For Dilator 12 Fr) 20 cm

EMDN U03010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89041335451434P 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 24 Fr (For Dilator 20 Fr) 17 cm, AMPL-CA-GP-001-R0, Amplatz Sheath 32 Fr (For Dilator 28 Fr) 22 cm, Amplatz Sheath 34 Fr (For Dilator 30 Fr) 17 cm, Amplatz Sheath 26 Fr (For Dilator 22 Fr) 17 cm, Amplatz Sheath 16 Fr (For Dilator 12 Fr) 20 cm
Primary DI / UDI-DI
89041335451430, 89041335572456, 89041335451980, 89041335451508, 89041335571534
Basic UDI-DI
89041335451434P, 89041335572455R, 89041335451985G, 89041335451504L, 89041335571535K
Direct Marketing DI
89041335451430
89041335572456
89041335451980
89041335451508
89041335571534
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 (5)

  • EUDAMED fdd8094f-9af8-4b99-95f7-3e833fcca7c7 61 fields · synced 22 Oct 2026
  • EUDAMED 89041335572456|89041335572455R 61 fields · synced 18 Jun 2026
  • EUDAMED 89041335451980|89041335451985G 61 fields · synced 19 Jun 2026
  • EUDAMED 89041335451508|89041335451504L 61 fields · synced 19 Jun 2026
  • EUDAMED 89041335571534|89041335571535K 61 fields · synced 9 Jul 2026