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Guide Wire

EUDAMED

Class IIa (EU MDR)

Ref SV520-1001Model SV520-1501, SV520-1001

by Hicren (Zhejiang) Medtech Co., Ltd.

Identity

Device Name
Guide Wire EUDAMED
Model / Reference
SV520-1501, SV520-1001 EUDAMED
SV520-1001 EUDAMED

Identifiers

Primary DI / UDI-DI
06936260814207 EUDAMED
Basic UDI-DI
69362608SV520-01QD EUDAMED
EMDN Code
P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Guide Wire by Hicren (Zhejiang) Medtech Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000025999
Authorised Representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Sources (1)

  • EUDAMED a4173f70-937d-48fe-84f1-3c2d7b1fd2f0 61 fields · synced Jul 9, 2026