TytoPro

Designed for professional use, TytoPro used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, no-touch infrared basal thermometer,…

Registry build 21.09.26

Designed for professional use, TytoPro used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, no-touch infrared basal thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672008 TytoCare, 07290016672015 Tyto Stethoscope and 07290016672022 Tyto Otoscope. TytoPro kits are shipped to the US in a logistic carton labeled with DI 17290016672036.

3manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Zhejiang (1), Guangdong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code DQD
Manufacturer City Province Registered as Device types
Yahorng Dongguan Electronic Co Ltd Guangdong Guangdong Contract manufacturer 8
ADC Ningbo Co., Ltd. Ningbo Zhejiang Exporter 13
Suzhou Melodicare Medical Technology Co., Ltd. Suzhou Jiangsu Manufacturer 3

Record

Regulatory record for TytoPro
Listed by Tyto Care, Ltd., Israel
FDA product code DQD
Device type Stethoscope, Electronic
Device class Class 2
Regulation 21 CFR 870.1875
Record published 2016-12-22
Record revised 2024-11-25 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Supplied as a kit Yes
Label carries manufacturing date, serial number
Packaging Logistic carton of 6

Catalogue Numbers

Catalogue numbers for TytoPro
Catalogue number Size Status
TytoPro In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
3M™ Littmann® 3M Company 29
Adscope® American Diagnostic Corp. 14
Littmann® 3M Company 13
RNK Products Rnk Products, Inc. 10
Tyto Stethoscope Tyto Care, Ltd. 5
Steth IO Steth IO 4
Heroic Faith Heroic Faith International Ltd. 3
Stethophone Pro Sparrow Acoustics Inc. 2
AeviceMD Aevice Health Pte. Ltd. 2
Eko Core 500 and CAC500 Founder’s Edition bundle Eko Devices, Inc. 1
Eko Core 500 and CAC500 Standard bundle Eko Devices, Inc. 1
Stethophone Sparrow Acoustics Inc. 1

Showing 12 of 79. All products under Stethoscope, Electronic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K252089 2026-03-12
K181612 2018-12-17
K160401 2016-10-19

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer