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Silicone Super Absorbent Dressing

EUDAMED

Class IIb (EU MDR)

Ref 20390954Model Silicone Super Absorbent Dressing with border (Type II)

by Winner Medical Co., Ltd.

Identity

Device Name
Silicone Super Absorbent Dressing EUDAMED
Model / Reference
Silicone Super Absorbent Dressing with border (Type II) EUDAMED
20390954 EUDAMED

Identifiers

Primary DI / UDI-DI
16942327069869 EUDAMED
Basic UDI-DI
694232707803FQ EUDAMED
EMDN Code
M04040702 SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES EUDAMED

Classification

Device Class
Class IIb 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

Silicone Super Absorbent Dressing by Winner Medical Co., Ltd. — Class IIb — 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-000005692
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 5d7a01e9-fbd8-4b7a-a5df-d1aea3d22dd9 61 fields · synced Jul 31, 2026