Sigknow Biomedical Co., Ltd.
Active in EUDAMEDTaiwanfrom SRN EUDAMED FDA SRN TW-MF-000026397 FEI 3025330366
- Devices
- 15
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- MDSS GmbHDE
What Sigknow Biomedical Co., Ltd. makes
Sigknow Biomedical Co., Ltd. manufactures single-use electrocardiographic electrodes and wearable ECG monitoring systems, including disposable ECG patches, recorders, and accompanying software for cardiac rhythm analysis. Their portfolio includes standalone ECG patches, dedicated recorders, and integrated systems with analysis tools for continuous or episodic heart monitoring.
The company’s devices are classified under EU Class I and Class II/IIa regulations, with corresponding entries in the EUDAQMED and FDA 510(k) registries. The manufacturer is based in Taiwan.
Catalogue
Search and filter all 15 devicesCompany details
- EUDAMED SRN
- TW-MF-000026397
- FDA FEI number
- 3025330366
- DUNS number
- 656154969
- EUDAMED status
- Active
- EUDAMED registered name
- Sigknow Biomedical Co., Ltd.
- EUDAMED abbreviated name
- Sigknow
- Registered address
- 10F.-2, No. 760, Sec. 4, Bade Road, 105, Taipei City, Taiwan
- Website
- www.sigknow.com
- [email protected]
- Phone
- 8862761257
- PRRC contact
- Albert Hung
Frequently asked questions
How many devices does SIGKNOW BIOMEDICAL CO., LTD. have in the registry?
The registry currently lists 15 devices for SIGKNOW BIOMEDICAL CO., LTD.. Devices recorded under merged duplicate company entries are counted once.
Which registries list SIGKNOW BIOMEDICAL CO., LTD.'s devices?
Among its 15 most recently registered devices, SIGKNOW BIOMEDICAL CO., LTD. has devices listed in EUDAMED (11 devices), FDA 510(k) (1 device) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do SIGKNOW BIOMEDICAL CO., LTD.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for SIGKNOW BIOMEDICAL CO., LTD.'s devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from SIGKNOW BIOMEDICAL CO., LTD. in the registry?
The most recently registered devices listed for SIGKNOW BIOMEDICAL CO., LTD. include EZYPRO ECG Recorder UG02, SIGKNOW EZYPRO ECG Patch UG02-P, EZYPRO Wearable ECG System – EZYPRO ECG Recorder, SIGKNOW ECG Patch, accessories, supporting software, and EZYPRO Analyzer and SIGKNOW EZYPRO ECG Patch UG03-P3S.