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Foam dressing
EUDAMEDClass IIb (EU MDR)
Ref FMD5110EModel Foam Dressing without Border (Type I)Ref FMD4110ERef 19721044Ref 701319Ref FKAB2020Model Foam dressing with border (Type III)Ref 702020Model Foam lite dressing without border (Type I)Ref 711020Model Foam dressing with border (Type II)Ref WIN7240710Ref 7011010Ref FB1001Model Foam lite dressing without border (Type II)Ref WIN7241210Ref WIN7240105Model Foam dressing without border (Type II)Ref WIN7240510Ref 701018Ref WIN7242010Ref FKAB1212Ref WIN7242110Ref 700505Ref 711515
Identity
- Device Name
- Foam dressing EUDAMED
- Model / Reference
- Foam Dressing without Border (Type I) EUDAMEDFMD5110E EUDAMEDFMD4110E EUDAMED19721044 EUDAMED701319 EUDAMEDFoam dressing with border (Type III) EUDAMEDFKAB2020 EUDAMEDFoam lite dressing without border (Type I) EUDAMED702020 EUDAMEDFoam dressing with border (Type II) EUDAMED711020 EUDAMEDWIN7240710 EUDAMED7011010 EUDAMEDFoam lite dressing without border (Type II) EUDAMEDFB1001 EUDAMEDWIN7241210 EUDAMEDFoam dressing without border (Type II) EUDAMEDWIN7240105 EUDAMEDWIN7240510 EUDAMED701018 EUDAMEDWIN7242010 EUDAMEDFKAB1212 EUDAMEDWIN7242110 EUDAMED700505 EUDAMED711515 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327035079 EUDAMED16942327066592 EUDAMED16942327043074 EUDAMED16942327082417 EUDAMED16941094088905 EUDAMED16942327044699 EUDAMED16942327058528 EUDAMED16941094070191 EUDAMED16942327026718 EUDAMED16942327068589 EUDAMED16941094070047 EUDAMED16941094089148 EUDAMED16941094070214 EUDAMED16942327060026 EUDAMED16941094069980 EUDAMED16941094088721 EUDAMED16941094070375 EUDAMED16942327032542 EUDAMED16942327000237 EUDAMED
- Basic UDI-DI
- 694232708960GG EUDAMED694232708954GM EUDAMED694232707881GC EUDAMED694232708955GP EUDAMED694232707880GA EUDAMED694232708959GX EUDAMED
- EMDN Code
- M04040601 POLYURETHANE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMEDGermany EUDAMEDHungary EUDAMEDSpain EUDAMEDIreland 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
Foam dressing by Winner Medical Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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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 | 694232708960GG | Class IIb | Active |
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Manufacturer
- Manufacturer
- Winner Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000005692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (19)
- EUDAMED ddb4d49f-6a90-4f0a-b064-92195f82d100 61 fields · synced Aug 3, 2026
- EUDAMED 3201b7a8-fe49-4cbb-91db-9ae75f41aa1b 61 fields · synced May 16, 2026
- EUDAMED 4d4fd8ad-9f2e-4935-a8a1-626e65d66431 61 fields · synced Jun 20, 2026
- EUDAMED 60c029ca-865e-4142-ad62-2836ec5b88e7 61 fields · synced Jun 20, 2026
- EUDAMED 3c4f70bb-c14e-4f69-a151-cedbe7a48069 61 fields · synced Jul 9, 2026
- EUDAMED cec6583a-bda4-4719-af37-206ca34cf0d4 61 fields · synced Jul 9, 2026
- EUDAMED 8bdf1332-02fd-44d6-a335-c3dbdf7c20e7 61 fields · synced Jul 10, 2026
- EUDAMED 0db3d221-287b-4413-9491-6ef65220c2bf 61 fields · synced Jul 10, 2026
- EUDAMED ae8bc6c9-8240-4ba9-8b19-3c238bb29243 61 fields · synced Jul 10, 2026
- EUDAMED 1d0754ac-f36c-43ab-a8f0-e8d5c2bef946 61 fields · synced Jul 12, 2026
- EUDAMED 0f6e894b-42da-4a97-a8e6-cd414a5e1f7b 61 fields · synced Jul 13, 2026
- EUDAMED 79b760b3-9612-4127-915a-da4301e08346 61 fields · synced Jul 13, 2026
- EUDAMED 3c5b8859-c580-4b9f-92bd-75e4878f4539 61 fields · synced Jul 16, 2026
- EUDAMED ab5cef5c-6b63-4ab4-a8e5-28d19b0883aa 61 fields · synced Jul 17, 2026
- EUDAMED bdc8e16a-52cb-4254-bd64-986cdd4d633b 61 fields · synced Jul 21, 2026
- EUDAMED 78c5c776-efb4-482c-b7ab-503a13fd9ab0 61 fields · synced Jul 22, 2026
- EUDAMED da36396d-9a80-4ace-9e84-5a4f194cb807 61 fields · synced Jul 24, 2026
- EUDAMED deeea50c-f750-410a-83bf-1bf2233bb358 61 fields · synced Jul 25, 2026
- EUDAMED dad2d2b3-b64f-4087-8a08-66761fa6000c 61 fields · synced Aug 3, 2026