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FLEX Vessel Prep System FSC 4-75

by Venturemed Group, Inc.

Ref FSC 7-75

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08636560003FLEXSG Basic UDI-DI 00863656000325UDI-DIDate7 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00863656000325 UDI-DI Date3 Apr 2023ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
FLEX Vessel Prep™ System EUDAMED
FLEX Vessel Prep System GUDID
Generic Name
Coronary angioplasty balloon catheter, cutting/scoring
Model / Ref / Catalog
FSC 7-75 EUDAMED
FSC 4-75 GUDID
Primary DI / UDI-DI
00863656000325
Basic UDI-DI
08636560003FLEXSG
Direct Marketing DI
00863656000325
FDA Product Code
PNO
EMDN Code
C010402020199 PTA dilatation catheters - other
GMDN Term
Coronary angioplasty balloon catheter, cutting/scoring
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1250
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Catheter Length — 75 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
FSC 7-75
GUDID
FSC 4-75
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Coronary angioplasty balloon catheter, cutting/scoring

Other devices from Venturemed Group, Inc.

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No