Identity
- Trade Name
- SINUSCOPE EUDAMEDFDA UDI
- Generic Name
- Rigid optical sinoscope FDA UDI
- Device Name
- SINUSCOPE EUDAMEDSinuscope 4mm Ø, 00°, 175mm L FDA UDI
- Model / Reference
- SN0300140 EUDAMEDSN0400175 EUDAMEDR00 FDA UDI
- Description
- Sinuscope 4mm Ø, 00°, 175mm L FDA UDI
Identifiers
- Catalog Number
- SN0400175 FDA UDI
- Primary DI / UDI-DI
- B366SN0400175 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B366NAENDOSCOPES2V EUDAMED
- Direct Marketing DI
- B366SN0400175 EUDAMED
- FDA Product Code
- EOB FDA UDI
- EMDN Code
- Z12021099 ENT ENDOSCOPY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Rigid optical sinoscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4760 FDA UDI
- Market of Registration
- Hungary 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
No
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
Sinuscope by EUSA Global Llc. — Class I — 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 | ++B366NAENDOSCOPES2V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- EUSA Global Llc.
- EUDAMED SRN
- US-MF-000003607
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 452df3a7-91d4-4eac-81f1-c10e199e3a52 61 fields · synced Jun 18, 2026
- FDA UDI 83225145-e2a8-4d87-8d4e-ab04306fe877 36 fields · synced May 30, 2026