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Amplatz Sheath

by Blue Neem Medical Devices Private Limited India EUDAMED

Ref BAST01202001

EMDN U03010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8905080BPDGH Basic UDI-DIDate21 Apr 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
Percutaneous Dilators
Model / Reference
BAST01202001
Primary DI / UDI-DI
08905080010739
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

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 98a40e19-51ba-4bab-8309-10adb5806be4 61 fields · synced 23 Oct 2026