Identity
- Trade Name
- OP-30 EUDAMEDOptomic FDA UDI
- Generic Name
- Flexible fibreoptic nasopharyngolaryngoscope FDA UDI
- Device Name
- NASO-PHARYNGOSCOPE EUDAMED
- Model / Reference
- 48073175 EUDAMEDOP-30 Naso-pharyngoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08436041580485 EUDAMEDFDA UDI
- Basic UDI-DI
- 84360415816443S EUDAMED
- FDA Product Code
- CAL FDA UDI
- EMDN Code
- Z12021005 NASAL PHARYNGO/LARYNGOSCOPES EUDAMED
- GMDN Term
- Flexible fibreoptic nasopharyngolaryngoscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5530 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
Hydrogen Peroxide FDA UDI
Category: Flexible fibreoptic nasopharyngolaryngoscope
Optomic by Optomic España Sa — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Flexible fibreoptic nasopharyngolaryngoscope.
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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 1e42a316-1cfa-4def-bf9b-cddb922f5c3b 32 fields · synced Jul 15, 2026
- EUDAMED 0e75478f-9d8d-4dac-adaf-78d5c838aa3b 61 fields · synced Jul 15, 2026