Identity
- Trade Name
- octenisan md nasal gel EUDAMED
- Device Name
- octenisan md nasal gel EUDAMED
- Model / Reference
- 70003046 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032651980536 EUDAMED
- Basic UDI-DI
- 4032651BSC00000033A9 EUDAMED
- EMDN Code
- Q030199 NASOPHARYNGEAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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
octenisan md nasal gel 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 | 4032651BSC00000033A9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Schülke & Mayr GmbH
- EUDAMED SRN
- DE-MF-000005701
Sources (1)
- EUDAMED fb6feaf7-61ea-4c11-8f33-8014be227a35 61 fields · synced Jul 10, 2026