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Polyurethane Foam Dressing
EUDAMEDClass IIa (EU MDR)
Ref F04180180Model Type F04Ref F037575Model Type F03Ref F03175175Ref F047585Ref F02100200Model Type F02Ref F04100100Ref F0450125Ref F02140200Ref F02100100Ref F02D60Ref F028080Ref F03125125Ref F04150150Ref F047575Ref F02150150Ref F04150200Ref F03100100Ref F019090Model Type F01Ref F016565Ref F04125125Ref F035050Ref F04100250Ref F04152184Ref F01200500Ref F03210210Ref F04200169Ref F04100300Ref F04215240Ref F03250300Ref F04100150Ref F02100150Ref F04175175Ref F04150180Ref F038080Ref F01102102Ref F04206242Ref F027575Ref F0478100Ref F017585Ref F04160200Ref F01200200Ref F04198140Ref F0455120Ref F03200175Ref F04129129Ref F04172175Ref F04130200Ref F015060Ref F03225200Ref F04182169
Identity
- Trade Name
- Polyurethane Foam Dressing EUDAMED
- Device Name
- Polyurethane Foam Dressing EUDAMED
- Model / Reference
- Type F04 EUDAMEDF04180180 EUDAMEDType F03 EUDAMEDF037575 EUDAMEDF03175175 EUDAMEDF047585 EUDAMEDType F02 EUDAMEDF02100200 EUDAMEDF04100100 EUDAMEDF0450125 EUDAMEDF02140200 EUDAMEDF02100100 EUDAMEDF02D60 EUDAMEDF028080 EUDAMEDF03125125 EUDAMEDF04150150 EUDAMEDF047575 EUDAMEDF02150150 EUDAMEDF04150200 EUDAMEDF03100100 EUDAMEDType F01 EUDAMEDF019090 EUDAMEDF016565 EUDAMEDF04125125 EUDAMEDF035050 EUDAMEDF04100250 EUDAMEDF04152184 EUDAMEDF01200500 EUDAMEDF03210210 EUDAMEDF04200169 EUDAMEDF04100300 EUDAMEDF04215240 EUDAMEDF03250300 EUDAMEDF04100150 EUDAMEDF02100150 EUDAMEDF04175175 EUDAMEDF04150180 EUDAMEDF038080 EUDAMEDF01102102 EUDAMEDF04206242 EUDAMEDF027575 EUDAMEDF0478100 EUDAMEDF017585 EUDAMEDF04160200 EUDAMEDF01200200 EUDAMEDF04198140 EUDAMEDF0455120 EUDAMEDF03200175 EUDAMEDF04129129 EUDAMEDF04172175 EUDAMEDF04130200 EUDAMEDF015060 EUDAMEDF03225200 EUDAMEDF04182169 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975489892306 EUDAMED06975489890432 EUDAMED06975489890548 EUDAMED06975489890586 EUDAMED06975489890371 EUDAMED06975489890074 EUDAMED06975489890562 EUDAMED06975489892337 EUDAMED06975489890326 EUDAMED06975489890401 EUDAMED06975489890357 EUDAMED06975489890470 EUDAMED06975489892269 EUDAMED06975489890579 EUDAMED06975489890050 EUDAMED06975489892276 EUDAMED06975489892283 EUDAMED06975489890067 EUDAMED06975489890319 EUDAMED06975489890272 EUDAMED06975489890623 EUDAMED06975489890418 EUDAMED06975489890616 EUDAMED06975489893044 EUDAMED06975489893150 EUDAMED06975489892474 EUDAMED06975489893198 EUDAMED06975489893112 EUDAMED06975489893419 EUDAMED06975489893624 EUDAMED06975489893013 EUDAMED06975489893280 EUDAMED06975489893020 EUDAMED06975489893839 EUDAMED06975489892719 EUDAMED06975489892481 EUDAMED06975489893761 EUDAMED06975489893006 EUDAMED06975489893105 EUDAMED06975489892566 EUDAMED06975489893297 EUDAMED06975489892511 EUDAMED06975489893181 EUDAMED06975489893075 EUDAMED06975489892467 EUDAMED06975489893099 EUDAMED06975489893747 EUDAMED06975489893846 EUDAMED06975489892993 EUDAMED06975489892672 EUDAMED06975489894058 EUDAMED
- Basic UDI-DI
- 697548989XLF042R EUDAMED697548989XLF032P EUDAMED697548989XLF022M EUDAMED697548989XLF012K EUDAMED
- EMDN Code
- M04040601,M04040602 EUDAMEDM04040601 POLYURETHANE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDFrance EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
Polyurethane Foam Dressing by Shandong Shinrise Medical Supplies Co., Ltd. — Class IIa — 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 | 697548989XLF042R | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shandong Shinrise Medical Supplies Co., Ltd.
- EUDAMED SRN
- CN-MF-000031315
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (51)
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- EUDAMED 57b06ff4-6243-47ef-badc-ffa5adc29404 61 fields · synced May 16, 2026
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- EUDAMED 47bb62cd-b197-43ff-9b61-3c6adebc4a20 61 fields · synced May 17, 2026
- EUDAMED 463c738c-78de-42ec-b2eb-17ea601d6796 61 fields · synced May 17, 2026
- EUDAMED 28b29346-ae25-43ae-a8ee-52c1db3af9e5 61 fields · synced May 17, 2026
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- EUDAMED a6ebd7b2-a238-43b1-9c32-6a6f95ad13cd 61 fields · synced May 19, 2026
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- EUDAMED 782daa83-d5bd-41c9-a976-20be6102ba0f 61 fields · synced May 19, 2026
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- EUDAMED 1c88ddda-0908-4390-8442-10e398e39acd 61 fields · synced May 19, 2026
- EUDAMED 91d01ae5-5aa8-47b2-af18-5e083df851cf 61 fields · synced Jun 14, 2026
- EUDAMED 199b593d-e419-4f42-8909-57faede05321 61 fields · synced Jun 18, 2026
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- EUDAMED 2a8822c0-abfc-41e9-8bac-93378d880af1 61 fields · synced Jul 12, 2026
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- EUDAMED 95e7f1b7-85e1-4fb8-a12b-9860c17de703 61 fields · synced Jul 12, 2026
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- EUDAMED c0236eeb-f132-4ba7-9233-9807e93e570b 61 fields · synced Jul 13, 2026
- EUDAMED dfea795d-bc95-43a5-894a-8a1339d11ea0 61 fields · synced Jul 14, 2026
- EUDAMED af3745d1-375c-4584-a78a-69a8be53680b 61 fields · synced Jul 16, 2026
- EUDAMED c753b570-7f8c-4cf7-89c2-a6ec2aa56ddd 61 fields · synced Jul 19, 2026
- EUDAMED 3ad125bd-dfd9-4a83-aeb4-41342bc8382c 61 fields · synced Jul 19, 2026
- EUDAMED 6bf8cb3e-1ca2-4ef2-9f3b-f2ba25863890 61 fields · synced Jul 21, 2026
- EUDAMED fd9edb77-37aa-4df8-9c9f-645a3ad39ecf 61 fields · synced Jul 25, 2026
- EUDAMED afc2b9c8-e0c1-48e1-be92-8cdbb7bdfc19 61 fields · synced Jul 26, 2026