Identity
- Trade Name
- Optomic FDA UDI
- Generic Name
- Otoscope, endoscopic FDA UDI
- Model / Reference
- OTOSCOPE OPT 2,7mm x 75mm x 0 AUT. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08436041580577 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- Otoscope, endoscopic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: Otoscope, endoscopic
Optomic by Optomic España Sa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Otoscope, endoscopic.
- PICCOLIGHT F.O. LED high power, otoscope, sky — Kirchner & Wilhelm GmbH + Co KG · Class I
- Otoscope Set, OMNI 3000, Deluxe, LED, Black, Rechargeable — Medical Devices (Pvt) Ltd · Class I
- COMBILIGHT F.O.30 otoscope with charg. plug 240 V + accu 3.5 V — Kirchner & Wilhelm GmbH + Co KG · Class I
- Otoscope — Ecleris · Class I
- Otoscope Set, VISIO 5, Classic F.O., 2.5V XENON — Medical Devices (Pvt) Ltd · Class I
- Otoscopes — Hangzhou Hawk Optical Electronic Instruments Co.,Ltd. · Class I
- Ear funnel, Ø 4.5 mm PU = 3 pcs. — Kirchner & Wilhelm GmbH + Co KG · Class I
- Otoscope Set, OMNI 3000, Deluxe, Xenon, Blue — Medical Devices (Pvt) Ltd · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Optomic España Sa
Sources (1)
- FDA UDI 17368df9-f943-4b68-95a4-6bef7a3998a1 32 fields · synced May 30, 2026