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GBUK Silicone Foam

EUDAMED

Class IIb (EU MDR)

Ref SF1020Model foamRef SF125125Ref SF1515Ref SF1010Ref SF075075

by Zhejiang Hongyu Medical Commodity Co., Ltd

Identity

Trade Name
GBUK Silicone Foam EUDAMED
Device Name
silicone dressings EUDAMED
Model / Reference
foam EUDAMED
SF1020 EUDAMED
SF125125 EUDAMED
SF1515 EUDAMED
SF1010 EUDAMED
SF075075 EUDAMED

Identifiers

Primary DI / UDI-DI
06938056216141 EUDAMED
06938056216103 EUDAMED
06938056216110 EUDAMED
06938056216097 EUDAMED
06938056216080 EUDAMED
Basic UDI-DI
69380562SD002NA 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 Foam 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 (5)

  • EUDAMED c34cd281-5ae0-4456-8812-d9d775b903fa 61 fields · synced Oct 6, 2026
  • EUDAMED 6e79e964-fb98-4555-b1d5-e8cbcc50c3db 61 fields · synced May 17, 2026
  • EUDAMED 33ed1620-9709-40cd-98ff-abf0c03c3c1a 61 fields · synced May 17, 2026
  • EUDAMED 6bc394a1-f99d-41a1-a80a-971363770677 61 fields · synced May 17, 2026
  • EUDAMED 34b242ea-dd6d-4a40-8a8b-022eed81a067 61 fields · synced May 18, 2026