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Silicone Scar Sheet

EUDAMED

Class I (EU MDR)

Ref 1.6in x 40 in(4cm x 1.0m)Model 1.6in x 40 in(4cm x 1.0m), 1.6in x 60 in(4cm x 1.5m), 1.6in x 120 in(4cm x 3m),customized size.Ref 1.6in x 60 in(4cm x 1.5m)Ref customized size

by Hubei Decen Biotechnology Co., Ltd

Identity

Device Name
Silicone Scar Sheet EUDAMED
Model / Reference
1.6in x 40 in(4cm x 1.0m), 1.6in x 60 in(4cm x 1.5m), 1.6in x 120 in(4cm x 3m),customized size. EUDAMED
1.6in x 40 in(4cm x 1.0m) EUDAMED
1.6in x 60 in(4cm x 1.5m) EUDAMED
customized size EUDAMED

Identifiers

Primary DI / UDI-DI
06973161441187 EUDAMED
06973161441194 EUDAMED
06973161441217 EUDAMED
Basic UDI-DI
697316144SSS01MB EUDAMED
EMDN Code
M03030199 ELASTIC FIXING BANDAGES - OTHER 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

Silicone Scar Sheet by Hubei Decen Biotechnology Co., Ltd — Class I — 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
Hubei Decen Biotechnology Co., Ltd
EUDAMED SRN
CN-MF-000003013
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (3)

  • EUDAMED a94e4a49-9584-4f95-8149-88d0e2cbf61b 61 fields · synced Sep 17, 2026
  • EUDAMED fd041d92-c8ba-4f7e-8289-3a9f94b528cf 61 fields · synced May 18, 2026
  • EUDAMED 11e67460-d494-4914-a012-662559ea7115 61 fields · synced May 19, 2026