Identity
- Trade Name
- OTOSCOPE EUDAMEDFDA UDI
- Generic Name
- Otoscope, endoscopic FDA UDI
- Device Name
- SINUSCOPE EUDAMEDOtoscope 3mm Ø, 00°, 100mm L FDA UDI
- Model / Reference
- SN0300140 EUDAMEDOT0300100 EUDAMEDR00 FDA UDI
- Description
- Otoscope 3mm Ø, 00°, 100mm L FDA UDI
Identifiers
- Catalog Number
- OT0300100 FDA UDI
- Primary DI / UDI-DI
- B366OT0300100 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B366NAENDOSCOPES2V EUDAMED
- Direct Marketing DI
- B366OT0300100 EUDAMED
- FDA Product Code
- ERA FDA UDI
- EMDN Code
- Z12149006 DIRECT OUTPATIENT OTOSCOPES EUDAMED
- GMDN Term
- Otoscope, endoscopic FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4770 FDA UDI
- Market of Registration
- Czechia 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Otoscope 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 1c40494f-881f-4860-9782-bdd8c3f1cc68 61 fields · synced Jul 26, 2026
- FDA UDI 64265793-3815-4b62-84eb-ba1f5d76e79b 36 fields · synced May 30, 2026