Skip to content

Amplatz Sheath

by Blue Neem Medical Devices Private Limited EUDAMED

Active European Union

Ref BAST01801701

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8905080BPDGH Basic UDI-DIDate21 Apr 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  • Withdrawn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
Percutaneous Dilators
Model / Reference
BAST01801701
Primary DI / UDI-DI
08905080010661
Basic UDI-DI
8905080BPDGH
EMDN Code
U03010101 Amplatz cannulas for urinary dilation
Device Class
Class IIa
Market of Registration
Czechia

Manufacturer details

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

Other devices from Blue Neem Medical Devices Private Limited

See all devices from Blue Neem Medical Devices Private Limited →

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