Identity
- Trade Name
- STROBOLUX III LED + HD EUDAMEDOptomic FDA UDI
- Generic Name
- Laryngostroboscope FDA UDI
- Device Name
- Stroboscope EUDAMED
- Model / Reference
- 28503843 EUDAMEDStrobolux III LED + HD Stroboscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08436041580263 EUDAMEDFDA UDI
- Basic UDI-DI
- 84360415807203A 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
- Spain 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
No
FDA UDI
Strobolux Iii Led + Hd by Optomic España S.a — 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 | 84360415807203A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Optomic España S.a
- EUDAMED SRN
- ES-MF-000003235
Sources (2)
- EUDAMED 09b11038-aaf7-4c40-8a5f-ee1f465fd7de 61 fields · synced Jun 18, 2026
- FDA UDI a585f7a7-0c45-42cd-830a-512cbb3e361b 32 fields · synced May 30, 2026