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Sterile Burn Gel
EUDAMEDClass IIb (EU MDR)
Ref 503.026003Model Dressing typeRef 403.056005Ref 503.026004Ref 403.001009Model Spray typeRef 503.026005Ref 503.026007Ref 503.026002Ref 403.001027
Identity
- Device Name
- Sterile Burn Gel EUDAMED
- Model / Reference
- Dressing type EUDAMED503.026003 EUDAMED403.056005 EUDAMED503.026004 EUDAMEDSpray type EUDAMED403.001009 EUDAMED503.026005 EUDAMED503.026007 EUDAMED503.026002 EUDAMED403.001027 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958868781399 EUDAMED16958868781375 EUDAMED16958868781405 EUDAMED16958868781146 EUDAMED16958868781412 EUDAMED16958868781429 EUDAMED16958868781382 EUDAMED16958868781320 EUDAMED
- Basic UDI-DI
- B-16958868781399 EUDAMEDB-16958868781375 EUDAMEDB-16958868781405 EUDAMEDB-16958868781146 EUDAMEDB-16958868781412 EUDAMEDB-16958868781429 EUDAMEDB-16958868781382 EUDAMEDB-16958868781320 EUDAMED
- EMDN Code
- M04040501 HYDROGEL DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Estonia EUDAMEDGreece EUDAMEDIreland EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Burn Gel by Roosin Medical Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16958868781399 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Roosin Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000021163
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (8)
- EUDAMED 820d016b-8e28-4a46-85b6-1bd6c336eeda 61 fields · synced Jul 26, 2026
- EUDAMED 5a1f93d4-bb5d-40e6-b7e8-c61bda626698 61 fields · synced May 17, 2026
- EUDAMED 63a56ed7-c123-4e68-9b5c-526362355c6f 61 fields · synced May 18, 2026
- EUDAMED cf7e8999-c519-4fdc-b6d5-1a7048e56655 61 fields · synced May 19, 2026
- EUDAMED 6238073f-5e97-4266-8a97-776f0e22370e 61 fields · synced May 19, 2026
- EUDAMED dbff6a48-59ec-4112-853d-0eb531dd6586 61 fields · synced May 19, 2026
- EUDAMED e33c82cd-71d0-4641-80d3-b3c394df7da5 61 fields · synced May 19, 2026
- EUDAMED ac44635f-a67d-4ac2-ae9b-ccbf80dcbe81 61 fields · synced Jun 18, 2026