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Scoreflex PTA

by OrbusNeich Medical (Shenzhen) Co., Ltd 115 variants

Ref AL620-154N

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

CE MDD

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06934955922527 Basic UDI-DI 06934955922527UDI-DIDate14 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06934955922527 UDI-DI Date1 Oct 2019ListedStatusListed 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

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
AL620-154N EUDAMED
AL620-154NU GUDID
Primary DI / UDI-DI
06934955922527
Basic UDI-DI
B-06934955922527
FDA Product Code
PNO, LIT
EMDN Code
C010402020101 PTA balloon dilatation catheters
GMDN Term
Peripheral angioplasty balloon catheter, basic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1250
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Catheter Length — 150 Centimeter
Guidewire Diameter — 0.014 Inch
Balloon Length — 15 Millimeter
Balloon Diameter — 2.0 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AL620-154N
GUDID
AL620-154NU
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

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

Related devices

Category: Peripheral angioplasty balloon catheter, basic

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

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

Properties

  • 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