Identity
- Trade Name
- octenisept gel EUDAMED
- Device Name
- octenisept gel EUDAMED
- Model / Reference
- 70003021 EUDAMED70002976 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032651980444 EUDAMED04032651980284 EUDAMED
- Basic UDI-DI
- 4032651BSC00000032A7 EUDAMED
- EMDN Code
- Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
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
octenisept gel by Schülke & Mayr GmbH — 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 | 4032651BSC00000032A7 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Schülke & Mayr GmbH
- EUDAMED SRN
- DE-MF-000005701
Sources (2)
- EUDAMED ba09b76d-51f7-4c6c-be02-3062ff418765 61 fields · synced Jul 9, 2026
- EUDAMED 81b54b90-cf49-4186-86a0-a97b3146f166 61 fields · synced May 18, 2026