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Scoreflex PTA

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

Ref AM660-204C

Scoreflex PTA (AM660-204C) is a device classified as Class IIa in the EU and Class II in the US made by OrbusNeich Medical (Shenzhen) Co., Ltd, registered in EUDAMED on 13 Apr 2026 (Basic UDI-DI B-06934955922237) and listed in FDA GUDID since 1 Oct 2019 (UDI-DI 06934955922237), active as of 25 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06934955922237 Basic UDI-DI 06934955922237UDI-DIDate13 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06934955922237 UDI-DI Date1 Oct 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-06934955922237 registered 13 Apr 2026 Active
  • FDA GUDID UDI-DI 06934955922237 listed 1 Oct 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06934955922237
  2. Registered EUDAMED B-06934955922237

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  • Withdrawn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
AM660-204C EUDAMED
AM660-204CU GUDID
Primary DI / UDI-DI
06934955922237
Basic UDI-DI
B-06934955922237
FDA product code
LIT, PNO
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 registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Balloon Diameter — 6.0 Millimeter
Balloon Length — 20 Millimeter
Guidewire Diameter — 0.014 Inch
Catheter Length — 90 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AM660-204C
GUDID
AM660-204CU
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

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

Related devices

Category: Peripheral angioplasty balloon catheter, basic

Similar devices in this category

Other devices filed under PTA BALLOON DILATATION CATHETERS.

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

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

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)