Identity
- Trade Name
- octenisan set EUDAMED
- Device Name
- octenisan set EUDAMED
- Model / Reference
- 70003054 EUDAMED70003064 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032651980550 EUDAMED04032651980659 EUDAMED
- Basic UDI-DI
- 4032651BSC00000046AJ EUDAMED
- EMDN Code
- Q030199 NASOPHARYNGEAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- for preoperative decontamination of skin, hair and nasal vestubles EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
octenisan set by Schülke & Mayr GmbH — 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 | 4032651BSC00000046AJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Schülke & Mayr GmbH
- EUDAMED SRN
- DE-PR-000039117
Sources (2)
- EUDAMED af25d614-28dd-4d65-aa1e-28486711934a 61 fields · synced Jul 9, 2026
- EUDAMED 6d0cabbf-2863-4c20-8216-c6b2e749d7e6 61 fields · synced May 18, 2026