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Gelfree-S3 Electrode Cap

EUDAMED

Class I (EU MDR)

Ref S3-1017Model S3-1032, S3-2032, S3-3032, S3-4032, S3-1023, S3-2023, S3-3023, S3-4023, S3-1022, S3-2022, S3-3022, S3-4022, S3-1020, S3-2020, S3-3020, S3-4020, S3-1017, S3-2017, S3-3017, S3-4017, S3-1011, S3-2011, S3-3011, S3-4011, S3-1008, S3-2008, S3-3008, S3-4008Ref S3-1032Ref S3-4011Ref S3-3022Ref S3-2020Ref S3-4017Ref S3-1022Ref S3-4020Ref S3-2022Ref S3-1023Ref S3-2023Ref S3-3032Ref S3-4023Ref S3-2032Ref S3-2011

by Wuhan Greentek Pty Ltd.

Identity

Device Name
Gelfree-S3 Electrode Cap EUDAMED
Model / Reference
S3-1032, S3-2032, S3-3032, S3-4032, S3-1023, S3-2023, S3-3023, S3-4023, S3-1022, S3-2022, S3-3022, S3-4022, S3-1020, S3-2020, S3-3020, S3-4020, S3-1017, S3-2017, S3-3017, S3-4017, S3-1011, S3-2011, S3-3011, S3-4011, S3-1008, S3-2008, S3-3008, S3-4008 EUDAMED
S3-1017 EUDAMED
S3-1032 EUDAMED
S3-4011 EUDAMED
S3-3022 EUDAMED
S3-2020 EUDAMED
S3-4017 EUDAMED
S3-1022 EUDAMED
S3-4020 EUDAMED
S3-2022 EUDAMED
S3-1023 EUDAMED
S3-2023 EUDAMED
S3-3032 EUDAMED
S3-4023 EUDAMED
S3-2032 EUDAMED
S3-2011 EUDAMED

Identifiers

Primary DI / UDI-DI
06970295340935 EUDAMED
06970295341956 EUDAMED
06970295340928 EUDAMED
06970295340997 EUDAMED
06970295341055 EUDAMED
06970295340966 EUDAMED
06970295340973 EUDAMED
06970295341079 EUDAMED
06970295340980 EUDAMED
06970295341017 EUDAMED
06970295340843 EUDAMED
06970295341963 EUDAMED
06970295341031 EUDAMED
06970295340164 EUDAMED
06970295340904 EUDAMED
Basic UDI-DI
697029534S3ZB EUDAMED
EMDN Code
N01010202 EEG EXTRACRANIC ELECTRODES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Czechia 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

Gelfree-S3 Electrode Cap by Wuhan Greentek Pty 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

EUDAMED SRN
CN-MF-000010400
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (15)

  • EUDAMED 21b36d38-5cb9-4c31-bba5-eed4e365c7f3 61 fields · synced Sep 18, 2026
  • EUDAMED c01f66c4-6297-4b9c-b8d7-e848010e5112 61 fields · synced May 16, 2026
  • EUDAMED 434f8b3a-362d-4c18-8b11-90bfce638e69 61 fields · synced May 16, 2026
  • EUDAMED 49a0c611-2541-4cbc-b78d-2e50cf199fb1 61 fields · synced May 17, 2026
  • EUDAMED ef6dfed1-b25a-4405-8479-a74e0e19795a 61 fields · synced May 17, 2026
  • EUDAMED 4b08c150-d382-410e-9804-f9d7183a004e 61 fields · synced May 17, 2026
  • EUDAMED 99ebcff2-42ca-446b-bf4a-40b9e66b1b97 61 fields · synced May 17, 2026
  • EUDAMED 0926f262-7889-45a3-b3a1-0ff33f301041 61 fields · synced May 17, 2026
  • EUDAMED 6696d657-333c-44a9-862e-8ba661d6c7c4 61 fields · synced May 17, 2026
  • EUDAMED 4c3d60c2-94de-4115-bb89-c1a025ebb1c6 61 fields · synced May 18, 2026
  • EUDAMED 789c7b3f-d669-45ec-baee-cfdeadf29c62 61 fields · synced May 18, 2026
  • EUDAMED 72064633-59c8-4abc-849c-01c0c3b8c6e5 61 fields · synced May 18, 2026
  • EUDAMED ee7fb61b-e401-4a06-bdba-c44a57628934 61 fields · synced May 18, 2026
  • EUDAMED f6c4a373-d855-44a5-a288-2c08256829bd 61 fields · synced May 19, 2026
  • EUDAMED 523b2d10-2cfc-48d4-8a39-588314ae7ed8 61 fields · synced May 19, 2026