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Sapphire II PRO Balloon Dilatation Catheter 501000812

by OrbusNeich Medical (ShenZhen) Co., Ltd.

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
United StatesGUDID listing GUDID Number06934955950025 UDI-DI Date23 Apr 2020ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED Number— Date—StatusActive

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  • Withdrawn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
Sapphire II PRO Balloon Dilatation Catheter
Generic Name
Coronary angioplasty balloon catheter, basic
Model / Reference
501000812
Primary DI / UDI-DI
06934955950025
FDA Product Code
LOX, LIT
GMDN Term
Coronary angioplasty balloon catheter, basic
Device Class
Class II
Regulation Number
870.5100, 870.1250
GUDID distribution status
In Commercial Distribution
Size
Balloon Diameter — 1 Millimeter
Balloon Length — 8 Millimeter

Related devices

Category: Peripheral angioplasty balloon catheter, basicCoronary 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 (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No