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ClearSheath

by Newtech Medical Devices Pvt. Ltd. India EUDAMED

Ref NT/IS/FST/0623Model M -Type Femoral Sheath

EMDN C0502

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890619416NTISQ2 Basic UDI-DIDate12 Feb 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
Introducer Sheath with Dilator
Model / Reference
M -Type Femoral Sheath, NT/IS/FST/0623
Primary DI / UDI-DI
08906194164257
Basic UDI-DI
890619416NTISQ2
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IN-MF-000045809
Authorised representative
Amstermed B.V. NL-AR-000001971

Related devices

Category: Vascular catheter introduction set, nonimplantable

Other devices from Newtech Medical Devices Pvt. Ltd.

See all devices from Newtech Medical Devices Pvt. Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Administering Medicine
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 4adee370-e0d7-4eaf-8777-4576acfabe82 61 fields · synced 22 Oct 2026