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Foam underwrap

EUDAMED

Class I (EU MDR)

Ref 0385Model prewrap pretape foam bandage foam underwrap bandage under tape foam wrap Underwrap Foam Bandage Underwrap Tape pre-tape 6cm*20m, 7cm*20m, 6cm*27m, 7cm*27m, or customized size 6cm*20m, 7cm*20m, 6cm*27m, 7cm*27m, or customized size

by Wuxi Wemade Healthcare Products Co., Ltd

Identity

Device Name
Foam underwrap EUDAMED
Model / Reference
prewrap pretape foam bandage foam underwrap bandage under tape foam wrap Underwrap Foam Bandage Underwrap Tape pre-tape 6cm*20m, 7cm*20m, 6cm*27m, 7cm*27m, or customized size 6cm*20m, 7cm*20m, 6cm*27m, 7cm*27m, or customized size EUDAMED
0385 EUDAMED

Identifiers

Primary DI / UDI-DI
06938799203859 EUDAMED
Basic UDI-DI
69387992FoamunderwrapEL EUDAMED
EMDN Code
M04010202 POLYURETHANE FIXING DRESSINGS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

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

Foam underwrap by Wuxi Wemade Healthcare Products Co., Ltd. — Class I — CE/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-000009786
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 36d97722-949c-4ee1-b0a3-5973ce78a61a 61 fields · synced Oct 7, 2026