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Procedure pack CSP0200 & CIV-Flex Cover

by AVENNS Medical GmbH Austria EUDAMED

Ref 0164

EMDN C03900299

Regulatory status

as of 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number912011008PP-CSP0200-CIVH2 Basic UDI-DIDate18 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
Procedure pack CSP0200 & CIV-Flex Cover
Model / Reference
0164
Primary DI / UDI-DI
09120110080035
Basic UDI-DI
912011008PP-CSP0200-CIVH2
EMDN Code
C03900299 Beating heart cardiosurgery devices - other
Device Class
Class III
Medical Purpose
The CSP0200 shockwave applicator is used to treat the hibernating myocardium during bypass surgery to improve left ventricular ejection fraction (LVEF)

Manufacturer details

EUDAMED SRN
AT-PR-000054589

Other devices from AVENNS Medical GmbH

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED cffb726b-d147-4e53-85ca-5e0793ba3be6 61 fields · synced 22 Oct 2026