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Disposable Negative Pressure Drainage System

EUDAMED

Class IIa (EU MDR)

Ref FYX-1GC-02Model I-GC-12, I-GC-15, I-GC-19, I-GC-24, I-GC-28, I-GC-32, I-LX-12, I-LX-15, I-LX-19, I-LX-24, I-LX-28, I-LX-32, II-GC-12, II-GC-15, II-GC-19, II-GC-24, II-GC-28, II-GC-32, II-LX-12, II-LX-15, II-LX-19, II-LX-24, II-LX-28, II-LX-32

by Shandong Wego New Life Medical Devices Co., Ltd.

Identity

Device Name
Disposable Negative Pressure Drainage System EUDAMED
Model / Reference
I-GC-12, I-GC-15, I-GC-19, I-GC-24, I-GC-28, I-GC-32, I-LX-12, I-LX-15, I-LX-19, I-LX-24, I-LX-28, I-LX-32, II-GC-12, II-GC-15, II-GC-19, II-GC-24, II-GC-28, II-GC-32, II-LX-12, II-LX-15, II-LX-19, II-LX-24, II-LX-28, II-LX-32 EUDAMED
FYX-1GC-02 EUDAMED

Identifiers

Primary DI / UDI-DI
06948534706453 EUDAMED
Basic UDI-DI
69485347DNPDSYA EUDAMED
EMDN Code
A0601010102 DRAINAGE SYSTEMS WITH RESERVOIR EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany 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

Disposable Negative Pressure Drainage System by Shandong Wego New Life Medical Devices Co., Ltd. — Class IIa — MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Shandong Wego New Life Medical Devices Co., Ltd.
EUDAMED SRN
CN-MF-000015950
Authorised Representative
MedNet EC-REP C IIb GmbH DE-AR-000011194

Sources (1)

  • EUDAMED 72047bed-8ae7-4174-94a2-74e12782e612 61 fields · synced Oct 7, 2026