Identity
- Trade Name
- Tyto Otoscope FDA UDI
- Generic Name
- Otoscope, direct FDA UDI
- Device Name
- The Tyto Otoscope is an electronic otoscope that enables capturing and transmission of video and still images of the external ear canal and tympanic membrane, whereby a clinician at one location on an IP network can view images and videos of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. FDA UDI
- Model / Reference
- Tyto Otoscope, Zamak, Gray, US FDA UDI
- Description
- The Tyto Otoscope is an electronic otoscope that enables capturing and transmission of video and still images of the external ear canal and tympanic membrane, whereby a clinician at one location on an IP network can view images and videos of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. FDA UDI
Identifiers
- Catalog Number
- 800-00024 FDA UDI
- Primary DI / UDI-DI
- 07290016672381 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- Otoscope, direct 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
Yes
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
Category: Otoscope, direct
Tyto Otoscope by Tyto Care Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Tyto Care Ltd
Sources (1)
- FDA UDI 34f4137b-02cf-47d3-85ef-cc49791bc1df 35 fields · synced Jun 8, 2026