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Silicone Foam Dressing
EUDAMEDClass IIb (EU MDR)
Ref GEN-14700Model Silicone Foam Dressing With Border (Type I)Ref GEN-14777Ref LQF-1010-BDRef 102 186Model Silicone foam dressing without borderRef 1010002041Model Silicone foam lite dressing without border (Type I)Ref 20313793Ref LQF-7575-BDRef LQF-1717-BDRef WIN5381010Model Silicone foam lite dressing with border (Type II)Ref 19721067Ref WIN5291505Ref 20313882Ref 1010002040Ref 19721009Ref SFD1130ERef 19721162Ref WIN5381003Ref PCEL1010Ref 19721021Ref WIN5291010Ref 251614Ref 19721096Ref 20313787Ref 251622Ref PCEL1030MRef WIN5385210Ref 251611Ref 102 185Ref 603-015798Ref 20313853Ref PCEL1010MRef WIN5391503Ref FKSILB1818Ref WIN5492105Ref WIN5381503Ref PCEL1020M
Identity
- Device Name
- Silicone Foam Dressing EUDAMED
- Model / Reference
- Silicone Foam Dressing With Border (Type I) EUDAMEDGEN-14700 EUDAMEDGEN-14777 EUDAMEDLQF-1010-BD EUDAMEDSilicone foam dressing without border EUDAMED102 186 EUDAMEDSilicone foam lite dressing without border (Type I) EUDAMED1010002041 EUDAMED20313793 EUDAMEDLQF-7575-BD EUDAMEDLQF-1717-BD EUDAMEDSilicone foam lite dressing with border (Type II) EUDAMEDWIN5381010 EUDAMED19721067 EUDAMEDWIN5291505 EUDAMED20313882 EUDAMED1010002040 EUDAMED19721009 EUDAMEDSFD1130E EUDAMED19721162 EUDAMEDWIN5381003 EUDAMEDPCEL1010 EUDAMED19721021 EUDAMEDWIN5291010 EUDAMED251614 EUDAMED19721096 EUDAMED20313787 EUDAMED251622 EUDAMEDPCEL1030M EUDAMEDWIN5385210 EUDAMED251611 EUDAMED102 185 EUDAMED603-015798 EUDAMED20313853 EUDAMEDPCEL1010M EUDAMEDWIN5391503 EUDAMEDFKSILB1818 EUDAMEDWIN5492105 EUDAMEDWIN5381503 EUDAMEDPCEL1020M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327039282 EUDAMED16942327064505 EUDAMED16942327024271 EUDAMED16941094077428 EUDAMED06942327037335 EUDAMED16942327012551 EUDAMED16942327042237 EUDAMED16942327004266 EUDAMED16941094075288 EUDAMED16942327062440 EUDAMED16942327079721 EUDAMED16942327023793 EUDAMED06942327021525 EUDAMED16942327028507 EUDAMED16942327036175 EUDAMED16942327008110 EUDAMED16941094089360 EUDAMED16942327013251 EUDAMED16942327060477 EUDAMED16942327079738 EUDAMED16942327012537 EUDAMED16942327037141 EUDAMED16942327021638 EUDAMED16942327008967 EUDAMED16942327002132 EUDAMED16941094075028 EUDAMED16942327055756 EUDAMED16941094077640 EUDAMED16941094093268 EUDAMED16942327068503 EUDAMED16942327013237 EUDAMED16942327080178 EUDAMED16941094089131 EUDAMED16942327080031 EUDAMED16941094089469 EUDAMED16942327022321 EUDAMED
- Basic UDI-DI
- 694232708961GJ EUDAMED694232708964GQ EUDAMED694232708965GS EUDAMED694232708963GN EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMEDGermany EUDAMEDEstonia EUDAMEDDenmark EUDAMEDPoland EUDAMEDFrance EUDAMEDItaly EUDAMEDSpain 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
Silicone Foam Dressing by Winner Medical 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 694232708961GJ | 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 (36)
- EUDAMED b38c3f20-7901-499b-9ffa-58d208ef22a7 61 fields · synced Sep 18, 2026
- EUDAMED 66852822-305b-4259-aded-960d7a265ba1 61 fields · synced May 18, 2026
- EUDAMED 5b17e76b-ec8d-4640-894d-b29b4535b95d 61 fields · synced Jul 8, 2026
- EUDAMED 570f1b5d-fd0f-4404-bb2d-f4fe9da010fe 61 fields · synced Jul 9, 2026
- EUDAMED a35c6ba8-19f2-42ee-89b8-e2a81600c743 61 fields · synced Jul 9, 2026
- EUDAMED c88ead81-0092-4d0b-ba5f-d488462fdea3 61 fields · synced Jul 9, 2026
- EUDAMED c90ecc84-4695-45ff-bc6c-2a9991ce92d1 61 fields · synced Jul 9, 2026
- EUDAMED 2ab643b7-34b1-48dc-a9b5-22ec2ef8f629 61 fields · synced Jul 9, 2026
- EUDAMED 8c6acd28-2a75-4c09-967a-15f5cbbd0cb8 61 fields · synced Jul 10, 2026
- EUDAMED 2664a15b-f558-4130-8c69-64c4d3d0dc86 61 fields · synced Jul 10, 2026
- EUDAMED 9c6235b0-a36e-415c-8e85-723b3fa25bad 61 fields · synced Jul 10, 2026
- EUDAMED 37884392-a345-4afc-bbbf-f9da1cd104c0 61 fields · synced Jul 10, 2026
- EUDAMED d93acf5e-3bb3-4a98-a539-cc570c05beb0 61 fields · synced Jul 11, 2026
- EUDAMED ddd589b0-254d-42da-a578-ad2e8807e84b 61 fields · synced Jul 12, 2026
- EUDAMED 9e922503-9bad-4ab5-b81f-58263008501e 61 fields · synced Jul 13, 2026
- EUDAMED 4e046ad9-d5da-4417-be22-fd39c6ccadd6 61 fields · synced Jul 14, 2026
- EUDAMED 3b97b705-9b02-48cb-9148-b3ca61baa61f 61 fields · synced Jul 14, 2026
- EUDAMED a24b88c6-c7f1-410a-a20f-426a678cc99a 61 fields · synced Jul 14, 2026
- EUDAMED a1251501-53e7-47e9-907d-efc44d5d5856 61 fields · synced Jul 15, 2026
- EUDAMED 2fc00041-a02c-4be4-8d05-33bc0e3b97bd 61 fields · synced Jul 16, 2026
- EUDAMED 582c76c8-acaf-4dd5-b82f-db17a338d682 61 fields · synced Jul 16, 2026
- EUDAMED 11291009-6027-471e-8386-dfe092612790 61 fields · synced Jul 16, 2026
- EUDAMED eb788b71-3e28-439a-92ca-66e0a1b8c9f7 61 fields · synced Jul 16, 2026
- EUDAMED ba513463-7d38-4515-b9d2-45ee3a54dcab 61 fields · synced Jul 17, 2026
- EUDAMED b2d970f9-f18e-4324-b53c-26c2aa9b30e3 61 fields · synced Jul 17, 2026
- EUDAMED 9f0c05a2-ad41-4b6b-8bd6-2951fb17d114 61 fields · synced Jul 19, 2026
- EUDAMED 68c2379d-6e80-47f2-acec-63359e7ade7b 61 fields · synced Jul 21, 2026
- EUDAMED cb308836-14f7-4417-b903-f22c27ab0e71 61 fields · synced Jul 21, 2026
- EUDAMED 7034c447-0020-4484-b47d-6a4f225c0656 61 fields · synced Jul 22, 2026
- EUDAMED 80189ff2-fc4e-4278-93b9-bdc781851f97 61 fields · synced Jul 25, 2026
- EUDAMED da48bd2b-257a-43a6-a77d-0c774738612e 61 fields · synced Jul 28, 2026
- EUDAMED c86c6637-e113-4224-937d-917d3b43ebf1 61 fields · synced Jul 29, 2026
- EUDAMED 69d80d89-9330-4e16-9ade-82917c4c08c5 61 fields · synced Jul 31, 2026
- EUDAMED f40f2c47-e445-4cb6-b354-3cea7d986278 61 fields · synced Aug 2, 2026
- EUDAMED 71412314-30d1-429e-b297-86beaf9e3891 61 fields · synced Aug 4, 2026
- EUDAMED 4cbf0617-a6b7-4c6d-8e38-cadb0596d4af 61 fields · synced Sep 18, 2026