Identity
- Model / Reference
- Sinuscopes EUDAMED31.0801a EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250480102138 EUDAMED
- Basic UDI-DI
- 42504801SINUSCOPESAL EUDAMED
- Direct Marketing DI
- 04250480102138 EUDAMED
- EMDN Code
- Z12021008 RHINOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
31.0801a by SCHÖLLY FIBEROPTIC 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 | 42504801SINUSCOPESAL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Schölly Fiberoptic Gmbh
- EUDAMED SRN
- DE-MF-000005618
Sources (1)
- EUDAMED 830fee8a-5e65-4b59-8269-43c1dde951ab 61 fields · synced Jun 18, 2026