Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Rigid optical sinoscope FDA UDI
- Device Name
- Sinuscope 2.7 x 187 mm, 0° FDA UDI
- Model / Reference
- Sinuscopes EUDAMED31.0810a EUDAMEDFDA UDI
- Description
- Sinuscope 2.7 x 187 mm, 0° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250480106730 EUDAMEDFDA UDI04250480102169 EUDAMED
- Basic UDI-DI
- 42504801SINUSCOPESAL EUDAMED
- Direct Marketing DI
- 04250480106730 EUDAMED04250480102169 EUDAMED
- FDA Product Code
- EOB FDA UDI
- EMDN Code
- Z12021008 RHINOSCOPES EUDAMED
- GMDN Term
- Rigid optical sinoscope FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4760 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
31.0810a by SCHÖLLY FIBEROPTIC GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42504801SINUSCOPESAL | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Schölly Fiberoptic Gmbh
- EUDAMED SRN
- DE-MF-000005618
Sources (3)
- EUDAMED e7f62c57-2526-49ab-9eeb-e2239af0e081 61 fields · synced Jul 25, 2026
- EUDAMED 6d3cc0dc-5b0c-4300-a475-4a5f66c2665b 61 fields · synced May 17, 2026
- FDA UDI beb837c7-fd0c-4006-a55d-711ed32c9d42 36 fields · synced May 29, 2026