← Back to catalogue
First Aid Dressing Bandage
EUDAMEDClass I (EU MDR)
Ref /Model FB6, FB8Ref F031Ref SAN-7011-202509版Ref PR-0005-03Ref F004Ref F003Ref PR-0005-01Ref NO.15Ref 0201004Ref 7.423.421Ref Kon-9x11Ref 14FB1005Ref REF 14FB1005Ref P-50006 00Ref MD1892Ref REF SAN-7017-202512版Ref 0201067Ref 0201071Ref 0201070
Identity
- Trade Name
- First Aid Dressing Bandage EUDAMED
- Device Name
- First Aid Dressing Bandage EUDAMED
- Model / Reference
- FB6, FB8 EUDAMED/ EUDAMEDF031 EUDAMEDSAN-7011-202509版 EUDAMEDPR-0005-03 EUDAMEDF004 EUDAMEDF003 EUDAMEDPR-0005-01 EUDAMEDNO.15 EUDAMED0201004 EUDAMED7.423.421 EUDAMEDKon-9x11 EUDAMED14FB1005 EUDAMEDREF 14FB1005 EUDAMEDP-50006 00 EUDAMEDMD1892 EUDAMEDREF SAN-7017-202512版 EUDAMED0201067 EUDAMED0201071 EUDAMED0201070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454730927 EUDAMED06951454758099 EUDAMED06951454798460 EUDAMED06951454788584 EUDAMED06951454725350 EUDAMED06951454786634 EUDAMED06951454781202 EUDAMED06951454736196 EUDAMED06951454757238 EUDAMED06951454755296 EUDAMED06951454793281 EUDAMED06951454716570 EUDAMED06951454756293 EUDAMED06951454738497 EUDAMED06951454746676 EUDAMED06951454789253 EUDAMED06951454740629 EUDAMED06951454759454 EUDAMED06951454797753 EUDAMED06951454728542 EUDAMED06951454799467 EUDAMED06951454738329 EUDAMED06951454734161 EUDAMED06951454718109 EUDAMED06951454739425 EUDAMED06951454798699 EUDAMED06951454742333 EUDAMED06951454765165 EUDAMED06951454745020 EUDAMED06951454758662 EUDAMED06951454772170 EUDAMED06951454746737 EUDAMED06951454785071 EUDAMED06951454717782 EUDAMED06951454738749 EUDAMED06951454780809 EUDAMED06951454758600 EUDAMED
- Basic UDI-DI
- 69514547300UW EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMEDM0303010103 ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN TWO DIRECTIONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Lithuania EUDAMEDDenmark EUDAMEDGermany EUDAMEDTürkiye EUDAMEDPoland EUDAMEDFinland EUDAMEDAustria EUDAMEDCzechia EUDAMEDNetherlands EUDAMEDItaly EUDAMEDHungary EUDAMEDIreland EUDAMEDFrance 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
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
First Aid Dressing Bandage by Gauke Healthcare Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
- ALIVIOVISCO — LIDERMED S.A. · Class I
- Gamgee BP – Non-sterile 45x45cm — Robinson Healthcare Ltd · Class I
- Herpatch — Sylphar nv · Class IIa
- N1 Psoriasis Intens Crème — PK Benelux BV · Class IIa
- Non-sterile Adhesive Dressings — Steroplast Healthcare Ltd · Class I
- Polyurethane Foam Dressing — Shandong Shinrise Medical Supplies Co., Ltd. · Class IIa
- Holland & Barrett Eczeem crème — PK Benelux BV · Class IIa
- Paraffin gauze dressings — Roosin Medical Co., Ltd. · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69514547300UW | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GAUKE Healthcare Co., Ltd
- EUDAMED SRN
- CN-MF-000013784
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (37)
- EUDAMED 1319288d-62ff-429c-a61d-ae65cfd066aa 61 fields · synced Oct 5, 2026
- EUDAMED 322aff6e-de57-4133-b624-386bcbf45e53 61 fields · synced May 11, 2026
- EUDAMED 3d43a40a-3368-4e4b-8a52-a14e64b829d1 61 fields · synced May 11, 2026
- EUDAMED 4c7b56ba-0e47-4d2d-b243-a51dd79f90c8 61 fields · synced May 11, 2026
- EUDAMED e3e93d9e-aac8-4d5b-b390-41e23503b51f 61 fields · synced May 11, 2026
- EUDAMED 1130c9cc-6a08-456f-b6a0-4ce3c47c314b 61 fields · synced May 11, 2026
- EUDAMED c6861336-ca1e-478f-b664-45c0555364a4 61 fields · synced May 16, 2026
- EUDAMED 4ee6a2b5-de9e-4220-a040-615bbe99c48c 61 fields · synced May 16, 2026
- EUDAMED bb5002b1-e09a-44c2-824f-6a8b42449ad5 61 fields · synced May 16, 2026
- EUDAMED e4427f89-7b45-4f12-82a9-ade4520de311 61 fields · synced May 16, 2026
- EUDAMED 9395e801-9aed-4988-9417-a5ba0411e244 61 fields · synced May 16, 2026
- EUDAMED ac156a06-c6e0-4f43-8453-427ee18888ca 61 fields · synced May 16, 2026
- EUDAMED 00abd4c1-4e8d-4752-bcac-b3a09bd5299b 61 fields · synced May 16, 2026
- EUDAMED c89b63ad-f333-403d-91da-9f566110b8ea 61 fields · synced May 17, 2026
- EUDAMED 4aca61b9-8cc1-438b-9e1a-4c94629d38d0 61 fields · synced May 17, 2026
- EUDAMED c0ff3ac1-ffdb-4bc2-9df8-f860b1f7be2d 61 fields · synced May 17, 2026
- EUDAMED 5420fae3-8632-47e1-8086-15ba476a38bb 61 fields · synced May 17, 2026
- EUDAMED 7467f42a-405e-4f91-8886-2e91d992aa6a 61 fields · synced May 17, 2026
- EUDAMED f62f004e-89e7-4823-b2f8-09afdd643f87 61 fields · synced May 17, 2026
- EUDAMED 3dc3dc6a-47a9-452d-acff-c45e9888e6ed 61 fields · synced May 17, 2026
- EUDAMED aa0e3210-0b09-4575-b48e-287d9ca23871 61 fields · synced May 17, 2026
- EUDAMED dd7605fd-33b5-4958-b46b-7942b12e4849 61 fields · synced May 17, 2026
- EUDAMED b76fc284-c7b4-4815-98e1-8eabdec68314 61 fields · synced May 18, 2026
- EUDAMED 254c5383-21ad-47ee-86a1-473dc7c201af 61 fields · synced May 18, 2026
- EUDAMED 0f70ccb4-5051-46c7-aa77-f20c20786f29 61 fields · synced May 18, 2026
- EUDAMED 40e6ad1a-7e0b-483c-bfa4-3b182db7c1bb 61 fields · synced May 18, 2026
- EUDAMED efc26e89-9720-4030-ab1e-1f9a320bc086 61 fields · synced May 18, 2026
- EUDAMED f0711d94-4b13-4b27-844b-209d82ef3bd7 61 fields · synced May 18, 2026
- EUDAMED ef85dc6b-b77d-4530-a376-7718561a4dd1 61 fields · synced May 19, 2026
- EUDAMED 0e23c12d-dccd-4091-9461-221feae9cdab 61 fields · synced May 19, 2026
- EUDAMED e343e355-52b4-439b-90e9-e2c504ad37f8 61 fields · synced May 19, 2026
- EUDAMED 51696738-a587-413e-8a4c-4ed4e3b92512 61 fields · synced May 19, 2026
- EUDAMED 0cb3d4b0-0ade-41ee-bc9d-583db51fb5e3 61 fields · synced May 19, 2026
- EUDAMED 6fd50b71-8517-4874-b5d3-d5100f611c6d 61 fields · synced Jul 14, 2026
- EUDAMED f3f01fe9-68ba-464e-81e2-ac71a369658e 61 fields · synced Jul 17, 2026
- EUDAMED 0f016dc8-1f42-4d3e-83cf-a721a865d470 61 fields · synced Jul 22, 2026
- EUDAMED 612a7526-c3c2-496f-b3ab-953f7375f0ee 61 fields · synced Jul 24, 2026