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Sol-Care Silicone Foam Dressing, with Border

EUDAMED

Class IIb (EU MDR)

Ref SFD1120ERef SFD1410ERef 19721050Model Silicone Foam Dressing With Border (Type I)

by Winner Medical Co., Ltd.

Identity

Trade Name
Sol-Care Silicone Foam Dressing, with Border EUDAMED
Device Name
Silicone Foam Dressing EUDAMED
Model / Reference
SFD1120E EUDAMED
SFD1410E EUDAMED
Silicone Foam Dressing With Border (Type I) EUDAMED
19721050 EUDAMED

Identifiers

Primary DI / UDI-DI
16942327081915 EUDAMED
16942327034119 EUDAMED
16942327026626 EUDAMED
Basic UDI-DI
694109403528EV EUDAMED
694232708961GJ EUDAMED
EMDN Code
M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
France EUDAMED
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

Sol-Care Silicone Foam Dressing, with Border 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

Manufacturer
Winner Medical Co., Ltd.
EUDAMED SRN
CN-MF-000005692
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (3)

  • EUDAMED 53db46ed-713d-4870-b3da-6898e2ffa982 61 fields · synced Aug 3, 2026
  • EUDAMED 0bc1b123-6f50-4fe1-88ee-18a267941ad9 61 fields · synced May 17, 2026
  • EUDAMED ea4f3fee-0b8f-4299-bb44-07854900fe66 61 fields · synced Jul 29, 2026