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Sapphire II (RX)

by OrbusNeich Medical (Shenzhen) Co., Ltd 27 variants

Ref 234-R-1720J, 234-R-4015J, 234-R-1512J, 234-R-1205J, 234-R-3530J, 234-R-1515J, 234-RL-2015J, 234-R-3030J, 234-R-1720J2, 234-R-1710J, 234-R-1008J, 234-RL-1205J, 234-RL-1720J2, 234-R-3520J, 234-R-2720J, 234-R-3020J, 234-RL-1210J, 234-R-2510J, 234-R-3012J, 234-R-2210J, 234-RL-1008J, 234-R-2220J, 234-RL-1515J, 234-R-2715J, 234-RL-2020J, 234-RL-1520J, 234-R-3510J, 234-R-1520J, 234-R-3010J, 234-R-2015J, 234-R-4020J, 234-R-1210J, 234-R-2520J, 234-R-2010J, 234-R-1510J, 234-R-1208J

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06934955921155 Basic UDI-DI Date21 Dec 2021RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Sapphire II (RX) Coronary Dilatation Catheter
Model / Reference
234-R-1720J, 234-R-4015J, 234-R-1512J, 234-R-1205J, 234-R-3530J, 234-R-1515J, 234-RL-2015J, 234-R-3030J, 234-R-1720J2, 234-R-1710J, 234-R-1008J, 234-RL-1205J, 234-RL-1720J2, 234-R-3520J, 234-R-2720J, 234-R-3020J, 234-RL-1210J, 234-R-2510J, 234-R-3012J, 234-R-2210J, 234-RL-1008J, 234-R-2220J, 234-RL-1515J, 234-R-2715J, 234-RL-2020J, 234-RL-1520J, 234-R-3510J, 234-R-1520J, 234-R-3010J, 234-R-2015J, 234-R-4020J, 234-R-1210J, 234-R-2520J, 234-R-2010J, 234-R-1510J, 234-R-1208J
Primary DI / UDI-DI
06934955921155, 06934955921445, 06934955921100, 06934955921056, 06934955921421, 06934955921117, 06934955921612, 06934955921353, 06934955921650, 06934955921131, 06934955921025, 06934955921506, 06934955921681, 06934955921414, 06934955921308, 06934955921346, 06934955921520, 06934955921230, 06934955921322, 06934955921209, 06934955921476, 06934955921223, 06934955921551, 06934955921292, 06934955921629, 06934955921568, 06934955921391, 06934955921124, 06934955921315, 06934955921186, 06934955921452, 06934955921070, 06934955921261, 06934955921162, 06934955921094, 06934955921063
Basic UDI-DI
B-06934955921155, B-06934955921445, B-06934955921100, B-06934955921056, B-06934955921421, B-06934955921117, B-06934955921612, B-06934955921353, B-06934955921650, B-06934955921131, B-06934955921025, B-06934955921506, B-06934955921681, B-06934955921414, B-06934955921308, B-06934955921346, B-06934955921520, B-06934955921230, B-06934955921322, B-06934955921209, B-06934955921476, B-06934955921223, B-06934955921551, B-06934955921292, B-06934955921629, B-06934955921568, B-06934955921391, B-06934955921124, B-06934955921315, B-06934955921186, B-06934955921452, B-06934955921070, B-06934955921261, B-06934955921162, B-06934955921094, B-06934955921063
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
EU market of registration
Germany

Manufacturer details

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

Related devices

Category: Coronary angioplasty balloon catheter, cutting/scoring

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Properties

  • Sterile

Other properties (10)

  • 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