Identity
- Trade Name
- TytoPro FDA UDI
- Generic Name
- Electronic acoustic stethoscope FDA UDI
- Device Name
- Designed for professional use, TytoPro used for comprehensive remote exam and telehealth. The TytoPro includes the Tyto Otoscope, Tyto Stethoscope, Tyto Exam Camera, Tyto Thermometer and disposable ear caps and tongue depressor blades. This is a convenience kit containing the following DIs: 07290016672534 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672343 Tyto Stethoscope and 07290016672350 Tyto Otoscope. TytoPro kits are shipped to the US in a 6 pack logistic carton labeled with DI 17290016672548 and 48 pack logistic carton labeled with 27290016672545. FDA UDI
- Model / Reference
- TytoPro G2 US FDA UDI
- Description
- Designed for professional use, TytoPro used for comprehensive remote exam and telehealth. The TytoPro includes the Tyto Otoscope, Tyto Stethoscope, Tyto Exam Camera, Tyto Thermometer and disposable ear caps and tongue depressor blades. This is a convenience kit containing the following DIs: 07290016672534 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672343 Tyto Stethoscope and 07290016672350 Tyto Otoscope. TytoPro kits are shipped to the US in a 6 pack logistic carton labeled with DI 17290016672548 and 48 pack logistic carton labeled with 27290016672545. FDA UDI
Identifiers
- Catalog Number
- 900-00002-007 FDA UDI
- Primary DI / UDI-DI
- 07290016672541 FDA UDI
- FDA Product Code
- FLL FDA UDIERA FDA UDIKYT FDA UDIDQD FDA UDI
- GMDN Term
- Electronic acoustic stethoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 FDA UDI874.4770 FDA UDI880.6350 FDA UDI870.1875 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infrared patient thermometer, skinOtoscope, directElectronic acoustic stethoscopeMulti-purpose digital medical camera
TytoPro by Tyto Care Ltd — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Tyto Care Ltd
Sources (1)
- FDA UDI fa3463a0-8a4e-4cae-b9c8-6fd9646e8482 35 fields · synced May 30, 2026