Sapphire NC 24

by OrbusNeich Medical (Shenzhen) Co., Ltd 98 variants

Ref 217-224-5J

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	NumberB-06934955949135 Basic UDI-DI 06934955949135UDI-DI	Date23 Dec 2021Registered	StatusActive

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

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name: Sapphire NC 24 Coronary Dilatation Catheter
Model / Reference: 217-224-5J

Primary DI / UDI-DI: 06934955949135
Basic UDI-DI: B-06934955949135
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

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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