Tyto Device
The Tyto Device G2 unit contains the Tyto Exam Camera and Tyto Thermometer. It is used also as the display (UI) and operation component of other TytoPro kit components: the Tyto Stethoscope…
The Tyto Device G2 unit contains the Tyto Exam Camera and Tyto Thermometer. It is used also as the display (UI) and operation component of other TytoPro kit components: the Tyto Stethoscope and Tyto Otoscope. As a spare part the Tyto Device is provided with catalog number 900-00050 and DI 17290016672531. Intended use for Tyto Exam Camera: The Tyto Camera is an electronic camera that enables capturing and transmission of video and still images of throat (w / w/o tongue depressor) and skin, 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. Intended use for Tyto Thermometer: The Tyto Thermometer is a clinical infrared thermometer intended for intermittent determination of human body temperature from the center of the forehead as the measurement site on people of all ages. The Tyto Thermometer is intended for use by both adult lay users and clinicians. It can be used both at home and in clinic environments
Who Else Makes It
Concentrated in Zhejiang (22), Jiangsu (14), Guangdong (7). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Hangzhou Aosi Healthcare Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 18 |
| Wenzhou Kangju Medical Instrument Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 15 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
Showing 12 of 53. All 53 manufacturers in China registered for Light, Examination, Medical, Battery Powered
Record
| Listed by | Tyto Care, Ltd., Israel |
|---|---|
| FDA product code | KYT |
| Device type | Light, Examination, Medical, Battery Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6350 |
| Premarket notification | Exempt |
| Record published | 2019-01-24 |
| Record revised | 2021-11-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Tyto Device | In distribution | |
| Tyto Device G2 Plastic Gray, US | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Penlight | Rashman Corp. | 58 |
| Adlite™ Plus | American Diagnostic Corp. | 20 |
| Metalite™ | American Diagnostic Corp. | 11 |
| MoleScope II | Metaoptima Technology Inc. | 10 |
| Metalite™ II | American Diagnostic Corp. | 10 |
| Firefly | Firefly Global | 9 |
| SurgiTel | Surgitel | 7 |
| PeriOptix | DEN-MAT Holdings, LLC | 6 |
| Dr. Vampa | Dr Vampa S.R.L. | 5 |
| Adlite™ II | American Diagnostic Corp. | 5 |
| Emsrun | Wuxi Emsrun Technology Co., Ltd. | 4 |
| MDF® | MDF Instruments Medifriend Inc. | 4 |
Showing 12 of 309. All products under Light, Examination, Medical, Battery Powered
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.