Identity
- Trade Name
- MICRO OPT Ø4mm x 185mm x 70º AUT. EUDAMEDOptomic FDA UDI
- Generic Name
- Rigid optical laryngopharyngoscope FDA UDI
- Device Name
- RIGID ENDOSCOPE - LARYNGOSCOPE EUDAMED
- Model / Reference
- 38533650 EUDAMEDMICRO LARYNGOSCOPE OPT 4mm x 185mm x 70 AUT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08436041580621 EUDAMEDFDA UDI
- Basic UDI-DI
- 84360415816423N EUDAMED
- Direct Marketing DI
- 08436041580621 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
- 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
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid optical laryngopharyngoscope
Optomic by Optomic España Sa — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Optomic España Sa
Sources (2)
- FDA UDI 7d636b94-8028-418e-b840-3c6e495cb36c 32 fields · synced Jul 9, 2026
- EUDAMED abca2397-6b2d-46a4-88e9-fc48063cf850 61 fields · synced Jul 9, 2026