Identity
- Trade Name
- LARINGOSCOPE EUDAMEDLaryngoPro FDA UDI
- Generic Name
- Rigid optical laryngopharyngoscope FDA UDI
- Device Name
- SINUSCOPE EUDAMEDLaryngoscope, 8mm Ø, 70°, 175mm L FDA UDI
- Model / Reference
- SN0300140 EUDAMEDLR0870000 EUDAMEDR00 FDA UDI
- Description
- Laryngoscope, 8mm Ø, 70°, 175mm L FDA UDI
Identifiers
- Catalog Number
- LR0870000 FDA UDI
- Primary DI / UDI-DI
- B366LR0870000 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B366NAENDOSCOPES2V EUDAMED
- Direct Marketing DI
- B366LR0870000 EUDAMED
- FDA Product Code
- CCW FDA UDI
- EMDN Code
- Z12021003 LARYNGOSCOPES EUDAMED
- GMDN Term
- Rigid optical laryngopharyngoscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5540 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
Category: Laryngoscope blade, reusable
Laringoscope by EUSA Global Llc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 cbb30ba0-097f-4159-b6ff-59ab996979c0 61 fields · synced Jun 18, 2026
- FDA UDI f8e8693d-3f50-4107-8930-4f401faddc3e 36 fields · synced May 30, 2026