Cotronic Technology Limited
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000023700
Part of Cotronic Technology Ltd
- Devices
- 18
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Cotronic Technology Limited makes
Cotronic Technology Limited manufactures digital pacifier thermometers, including the model TM-03, designed for measuring oral temperature in infants and young children. These devices provide digital readouts for precise body temperature monitoring, intended for home use.
The company’s digital pacifier thermometers are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where they must comply with applicable FDA requirements for safety and performance.
Catalogue
Search and filter all 18 devicesCompany details
- EUDAMED SRN
- CN-MF-000023700
- EU VAT number
- 914403005030448XY
- EUDAMED status
- Active
- EUDAMED registered name
- Cotronic Technology Ltd
- Registered address
- 518000, Shenzhen, China
- [email protected]
- Phone
- 00852-26022021
- PRRC contact
- wendy zeng
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 3 Nov 2030
DNV Product Assurance AS 2460 1 certificate
- C604081 Active
Quality management system EU MDR
- Issued
- 3 Nov 2025
- Expires
- 3 Nov 2030
Frequently asked questions
How many devices does Cotronic Technology Limited have in the registry?
The registry currently lists 18 devices for Cotronic Technology Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cotronic Technology Limited's devices?
Among its 18 most recently registered devices, Cotronic Technology Limited has devices listed in EUDAMED (17 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cotronic Technology Limited's devices fall under?
Among its 18 most recently registered devices, the classes recorded for Cotronic Technology Limited's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Cotronic Technology Limited?
EUDAMED lists 1 certificate for Cotronic Technology Limited (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2025-11-03.
What are the newest devices from Cotronic Technology Limited in the registry?
The most recently registered devices listed for Cotronic Technology Limited include Electronic Thermometer, nasal aspirator, DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03) and Nasal irrigation.