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Scoreflex PTA

by OrbusNeich Medical (Shenzhen) Co., Ltd China EUDAMEDGUDID

Ref AL625-404N

Product code LITEMDN C0104010202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06934955922572 Basic UDI-DIDate14 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06934955922572 UDI-DIDate1 Oct 2019ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Scoreflex PTA EUDAMED
Scoreflex PTA Scoring Balloon Catheter GUDID
Generic Name
Peripheral angioplasty balloon catheter, basic
Device Name
Scoreflex PTA Balloon Dilatation Catheter
Model / Reference
AL625-404N EUDAMED
AL625-404NU GUDID
Primary DI / UDI-DI
06934955922572
Basic UDI-DI
B-06934955922572
FDA Product Code
LIT, PNO
EMDN Code
C0104010202 Cardiac angiography guide catheters
GMDN Term
Peripheral angioplasty balloon catheter, basic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1250
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution
Size
Balloon Length — 40 Millimeter
Guidewire Diameter — 0.014 Inch
Catheter Length — 150 Centimeter
Balloon Diameter — 2.5 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AL625-404N
GUDID
AL625-404NU
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000011345
Authorised representative
Quality First International OÜ EE-AR-000004308

Other devices from OrbusNeich Medical (Shenzhen) Co., Ltd

See all devices from OrbusNeich Medical (Shenzhen) Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (16)
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (2)

  • EUDAMED c3877683-18c8-4d6b-bd38-ac568001c01d 61 fields · synced 22 Oct 2026
  • FDA UDI bfe29823-f848-4dc1-9a8a-2e31d242cf21 36 fields · synced 30 May 2026