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Alvision

by Alvimedica Tibbi Urunler San. ve Dis Tic. A.S. 207 variants

Part of a family of 207 devices: see the family page

Ref 501110188428

Alvision (501110188428) is a Class III device made by Alvimedica Tibbi Urunler San. ve Dis Tic. A.S., registered in EUDAMED on 27 Mar 2025 (Basic UDI-DI 086991955Alvision5D) with CE/MDR certificate 0425-MDR-006770-00 valid until 3 Jul 2028, active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

3 Jul 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier ICIM S.P.A.

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number086991955Alvision5D Basic UDI-DI 08699195526390UDI-DIDate27 Mar 2025RegisteredStatusActive

Official records

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 0425-MDR-006770-00 Active

    Technical documentation EU MDR

    Certifier
    ICIM S.P.A. 0425
    Issued
    4 Jul 2023
    Expires
    3 Jul 2028
  • 0425-MDR-006771-00 Active

    Quality management system EU MDR

    Certifier
    ICIM S.P.A. 0425
    Issued
    4 Jul 2023
    Expires
    3 Jul 2028

Timeline

5 dated events

  1. Certificate issued EUDAMED 0425-MDR-006770-00
  2. Certificate issued EUDAMED 0425-MDR-006771-00
  3. Registered EUDAMED 086991955Alvision5D
  4. Certificate expires EUDAMED 0425-MDR-006770-00
  5. Certificate expires EUDAMED 0425-MDR-006771-00

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Alvision Interventional Cardiology Diagnostic Catheter
Model / reference
501110188428
Primary DI / UDI-DI
08699195526390
Basic UDI-DI
086991955Alvision5D
Direct marketing DI
08699195526390
EMDN code
C0104010101 Cardiac angiography diagnostic catheters
Device class
Class III
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000029915

Similar devices in this category

Other devices filed under CARDIAC ANGIOGRAPHY DIAGNOSTIC CATHETERS.

Other devices from Alvimedica Tibbi Urunler San. ve Dis Tic. A.S.

See all devices from Alvimedica Tibbi Urunler San. ve Dis Tic. A.S. →

Properties

  • Supplied sterile
Other properties (13, all answered No)