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Formula™ 535

by Cook Incorporated 56 variants

Ref FOV535-35-80-10-20

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00827002567634 Basic UDI-DI 00827002567634UDI-DIDate6 May 2026RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
Formula™ 535 Vascular Balloon-Expandable Stent
Model / Reference
FOV535-35-80-10-20
Primary DI / UDI-DI
00827002567634
Basic UDI-DI
B-00827002567634
EMDN Code
P070402020101 Stainless steel peripheral vascular bare metal stents
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000003180
Authorised representative
COOK MEDICAL EUROPE LIMITED IE-AR-000000907

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

  • Sterile
  • Implantable

Other properties (9)

  • 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