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31.0802a
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 31.0802aModel Sinuscopes
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Rigid optical sinoscope FDA UDI
- Device Name
- Sinuscope 4 x 175 mm, 30° FDA UDI
- Model / Reference
- Sinuscopes EUDAMED31.0802a EUDAMEDFDA UDI
- Description
- Sinuscope 4 x 175 mm, 30° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250480102145 EUDAMED04250480106655 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504801SINUSCOPESAL EUDAMED
- Direct Marketing DI
- 04250480102145 EUDAMED04250480106655 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
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
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
31.0802a by SCHÖLLY FIBEROPTIC GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142249 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 42504801SINUSCOPESAL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Schölly Fiberoptic Gmbh
- EUDAMED SRN
- DE-MF-000005618
Sources (4)
- EUDAMED b754301a-6403-4a4b-8e2f-2f0c272b78a8 61 fields · synced Jul 9, 2026
- EUDAMED 3fc65b17-51ee-4d04-8df9-702e41ff181b 61 fields · synced May 16, 2026
- FDA UDI 4e31a729-7211-4c69-9b7e-77158b95b062 36 fields · synced May 30, 2026
- FDA 510(k) K142249 1 fields · synced May 18, 2026