Identity
- Trade Name
- LARYNGOSTROBOSCOPES EUDAMEDLARYNGOSTROBOSCOPE FDA UDI
- Generic Name
- Laryngostroboscope FDA UDI
- Device Name
- LARYNGOSTROBOSCOPE EUDAMEDFDA UDI
- Model / Reference
- SL103G21 EUDAMEDSL2103G21 EUDAMEDRX1 FDA UDI
- Description
- LARYNGOSTROBOSCOPE FDA UDI
Identifiers
- Catalog Number
- SL103G21 FDA UDI
- Primary DI / UDI-DI
- B366SL103G21 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B366U1STROBOLEDJ9 EUDAMED
- Direct Marketing DI
- B366SL103G21 EUDAMED
- FDA Product Code
- EQL FDA UDI
- EMDN Code
- Z12021010 LARYNGOSTROBOSCOPES EUDAMED
- GMDN Term
- Laryngostroboscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4750 FDA UDI
- Market of Registration
- Italy 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
Laryngostroboscopes 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 | ++B366U1STROBOLEDJ9 | 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 0d2b5005-f9cb-40c4-bac8-697f5d0bdd41 61 fields · synced Jul 24, 2026
- FDA UDI 3b8538b6-d718-4f36-98d6-7706a9d6f3c3 36 fields · synced May 24, 2026