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Amplatz Sheath

by Aster Medispro Private Limited India EUDAMED

Ref AMPL-CA-GP-001-R0Model Amplatz Sheath 30 Fr (For Dilator 26 Fr) 17 cm, Amplatz Sheath 20 Fr (For Dilator 16 Fr) 17 cm, Amplatz Sheath 16 Fr (For Dilator 12 Fr) 17 cm, Amplatz Sheath 24 Fr (For Dilator 20 Fr) 20 cm, Amplatz Sheath 26 Fr (For Dilator 22 Fr) 20 cm, Amplatz Sheath 28 Fr (For Dilator 24 Fr) 20 cm, Amplatz Sheath 34 Fr (For Dilator 30 Fr) 22 cm, Amplatz Sheath 22 Fr (For Dilator 18 Fr) 20 cm

EMDN U03010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890413354517452 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 23 Oct 2026

Device Name
Amplatz Sheath
Model / Reference
Amplatz Sheath 30 Fr (For Dilator 26 Fr) 17 cm, AMPL-CA-GP-001-R0, Amplatz Sheath 20 Fr (For Dilator 16 Fr) 17 cm, Amplatz Sheath 16 Fr (For Dilator 12 Fr) 17 cm, Amplatz Sheath 24 Fr (For Dilator 20 Fr) 20 cm, Amplatz Sheath 26 Fr (For Dilator 22 Fr) 20 cm, Amplatz Sheath 28 Fr (For Dilator 24 Fr) 20 cm, Amplatz Sheath 34 Fr (For Dilator 30 Fr) 22 cm, Amplatz Sheath 22 Fr (For Dilator 18 Fr) 20 cm
Primary DI / UDI-DI
89041335451744, 89041335451294, 89041335451058, 89041335571916, 89041335572074, 89041335572142, 89041335572524, 89041335571848
Basic UDI-DI
890413354517452, 89041335451294V, 89041335451054F, 89041335571915T, 89041335572075H, 89041335572145E, 89041335572525N, 89041335571845W
Direct Marketing DI
89041335451744
89041335451294
89041335451058
89041335571916
89041335572074
89041335572142
89041335572524
89041335571848
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 (8)

  • EUDAMED ae2f97fd-5a9a-423c-b670-2fa2f5690b78 61 fields · synced 23 Oct 2026
  • EUDAMED 89041335451294|89041335451294V 61 fields · synced 18 Jun 2026
  • EUDAMED 89041335451058|89041335451054F 61 fields · synced 19 Jun 2026
  • EUDAMED 89041335571916|89041335571915T 61 fields · synced 19 Jun 2026
  • EUDAMED 89041335572074|89041335572075H 61 fields · synced 9 Jul 2026
  • EUDAMED 89041335572142|89041335572145E 61 fields · synced 9 Jul 2026
  • EUDAMED 89041335572524|89041335572525N 61 fields · synced 17 Sep 2026
  • EUDAMED 89041335571848|89041335571845W 61 fields · synced 17 Sep 2026