Apexus

by Polyrey Medical Tech(Suzhou) Co., Ltd. 75 variants

Ref IIaModel 020-1500020

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

Region	Authorization	Number	Date	Status
European Union	CE/MDD	NumberB-06955454120016 Basic UDI-DI 06955454120016UDI-DI	Date25 Mar 2024Registered	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Withdrawn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: Balloon Dilatation Catheter
Model / Reference: 020-1500020, IIa

Primary DI / UDI-DI: 06955454120016
Basic UDI-DI: B-06955454120016
EMDN Code: C010402020101 PTA balloon dilatation catheters

Device Class: Class IIa
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000037473
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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See all devices from Polyrey Medical Tech(Suzhou) Co., Ltd. →

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