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Sapphire NC ULTRA Coronary Dilatation Catheter 8232-008-11

by OrbusNeich Medical (ShenZhen) Co., Ltd.

Ref 8232-008-11

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

CE MDR

Valid until

31 Jul 2029

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 797598 Date18 Aug 2026IssuedStatusActive expires 31 Jul 2029
United StatesGUDID listing GUDID Number06934955982316 UDI-DI Date20 Jan 2025ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 797598 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    18 Aug 2026
    Expires
    31 Jul 2029
    Reason
    Change approved

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Sapphire NC ULTRA EUDAMED
Sapphire NC ULTRA Coronary Dilatation Catheter GUDID
Generic Name
Coronary angioplasty balloon catheter, basic
Model / Reference
8232-008-11
Primary DI / UDI-DI
06934955982316
Basic UDI-DI
69349559821ZQ
Direct Marketing DI
06934955982316
510(k) Number
FDA Product Code
LOX
EMDN Code
C010401020101 Ptca balloon dilation catheters
GMDN Term
Coronary angioplasty balloon catheter, basic
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.5100
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Coronary angioplasty balloon catheter, basic

Cleared under the same submission (K233499)

Show all (12)

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

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

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No