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Sutrisept w Gel 100 ml
EUDAMEDClass III (EU MDR)
Ref 06.3838.100Model Sutrisept w Gel 100 ml
by ACTO GmbH
Identity
- Trade Name
- Sutrisept w Gel 100 ml EUDAMED
- Device Name
- Wound Care Gel EUDAMED
- Model / Reference
- Sutrisept w Gel 100 ml EUDAMED06.3838.100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05906190437204 EUDAMED
- Basic UDI-DI
- B-05906190437204 EUDAMED
- EMDN Code
- M040412 ANTISEPTICS-BASED DRESSINGS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Sutrisept w Gel 100 ml by ACTO GmbH — Class III — CE/MDR — 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-05906190437204 | Class III | Active |
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Manufacturer
- Manufacturer
- ACTO GmbH
- EUDAMED SRN
- DE-MF-000019128
Sources (1)
- EUDAMED f237dd83-9067-4d91-b3ea-d22c43747708 61 fields · synced Oct 6, 2026