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GBUK Silicone wound contact layer

EUDAMED

Class IIb (EU MDR)

Ref SWCD1515Model silconeRef SWCD2030Ref SWCD05075Ref SWCD1020

by Zhejiang Hongyu Medical Commodity Co., Ltd

Identity

Trade Name
GBUK Silicone wound contact layer EUDAMED
Device Name
silicone dressings EUDAMED
Model / Reference
silcone EUDAMED
SWCD1515 EUDAMED
SWCD2030 EUDAMED
SWCD05075 EUDAMED
SWCD1020 EUDAMED

Identifiers

Primary DI / UDI-DI
06938056216295 EUDAMED
06938056216288 EUDAMED
06938056216233 EUDAMED
06938056216264 EUDAMED
Basic UDI-DI
69380562SD004NE EUDAMED
EMDN Code
M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
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

GBUK Silicone wound contact layer by Zhejiang Hongyu Medical Commodity 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
Zhejiang Hongyu Medical Commodity Co., Ltd
EUDAMED SRN
CN-MF-000008204
Authorised Representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Sources (4)

  • EUDAMED e6f11395-ba86-493b-bb8f-dc042eb94e8a 61 fields · synced Oct 6, 2026
  • EUDAMED 345cfbb4-08f9-498f-a4df-6d17135cefd1 61 fields · synced May 17, 2026
  • EUDAMED cdc4bbde-e3b2-4b9a-94e8-dc764a0dbff4 61 fields · synced May 18, 2026
  • EUDAMED e92cb791-3de5-4d26-9b9f-f7eacdcad331 61 fields · synced May 18, 2026