Foam dressing

by Winner Medical Co., Ltd. 32 variants

Ref FKAB2020Model Foam dressing with border (Type III)

Active European Union

CE MDR

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number694232708954GM Basic UDI-DI 16941094088905UDI-DI	Date27 May 2026Registered	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Withdrawn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/MDR Active

Specification

EUDAMED

Device Name: Foam dressing
Model / Reference: Foam dressing with border (Type III), FKAB2020

Primary DI / UDI-DI: 16941094088905
Basic UDI-DI: 694232708954GM
EMDN Code: M04040601 Polyurethane dressings, non-combined

Device Class: Class IIb
EU market of registration: Spain

Manufacturer details

EUDAMED SRN: CN-MF-000005692
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Winner Medical Co., Ltd.

Synthetic non-woven products with X-ray detectable element

Class IIa
Gauze products with X-ray detectable element

Class IIa
Silicone Foam Dressing

Class IIb
Supplementary drape

Class I
Synthetic Non-woven Surgical Gown

Class I
Super Absorbent Dressing

Class IIb

See all devices from Winner Medical Co., Ltd. →

Properties

Sterile

Other properties (12)

Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No