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Cutiderm Paraffin Gauze Dressing 5cm x 5cm - Box of 20

EUDAMED

Class IIa (EU MDR)

Ref 405.028002

by Roosin Medical Co., Ltd.

Identity

Trade Name
Cutiderm Paraffin Gauze Dressing 5cm x 5cm - Box of 20 EUDAMED
Device Name
Paraffin Gauze Dressing EUDAMED
Model / Reference
405.028002 EUDAMED

Identifiers

Primary DI / UDI-DI
26958868783017 EUDAMED
Basic UDI-DI
B-26958868783017 EUDAMED
EMDN Code
M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER 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

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial

Cutiderm Paraffin Gauze Dressing 5cm x 5cm - Box of 20 by Roosin Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Roosin Medical Co., Ltd.
EUDAMED SRN
CN-MF-000021163
Authorised Representative
Prolinx GmbH DE-AR-000005129

Sources (1)

  • EUDAMED 57093d56-fb33-4f76-96da-1dfaf988bfbb 61 fields · synced Jul 11, 2026