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Medical Imaging Equipment – Cath Lab

by Innvolution Healthcare Private Limited

Ref FD2115100Model PINNACLE AGILE FD2115100

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-+G281FD21151000 Basic UDI-DI +G281FD21151000UDI-DIDate2 Nov 2023RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Withdrawn

Specification

EUDAMED

Device Name
Medical Imaging Equipment – Cath Lab
Model / Reference
PINNACLE AGILE FD2115100, FD2115100
Primary DI / UDI-DI
+G281FD21151000
Basic UDI-DI
B-+G281FD21151000
EMDN Code
Z11030102 Stationary angiography systems for angiographic and cardiologic studies
Device Class
Class IIb
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
IN-MF-000013689
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Innvolution Healthcare Private Limited

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No