MEZOO Co., Ltd.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED SRN KR-MF-000039441
- Devices
- 2
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What MEZOO Co., Ltd. makes
MEZOO Co., Ltd. manufactures the HiCardi+ H100, a medical device designed for cardiac monitoring and diagnostic purposes, likely incorporating advanced electrocardiogram (ECG) technology for real-time heart rhythm analysis.
The HiCardi+ H100 is classified as a Class II device under FDA regulations and is authorised via the 510(k) clearance pathway. The company is based in the United States.
Catalogue
Wearable ECG & Arrhythmia diagnosis and monitor Ref HiCardi+ SmartPatch
Regimes: CE MDD Registry: EUDAMEDHiCardi+ H100 Ref K232670
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- KR-MF-000039441
- EUDAMED status
- Active
- EUDAMED registered name
- MEZOO Co., Ltd.
- Registered address
- 200, Gieopdosi-ro, Jijeong-myeon, 26354, Wonju-si, Gangwon-do, South Korea
- Website
- www.me-zoo.com/
- [email protected]
- Phone
- +82 2 538 1006
- PRRC contact
- Mi Hye Song
Frequently asked questions
How many devices does MEZOO Co., Ltd. have in the registry?
The registry currently lists 2 devices for MEZOO Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list MEZOO Co., Ltd.'s devices?
Among its 2 most recently registered devices, MEZOO Co., Ltd. has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do MEZOO Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for MEZOO Co., Ltd.'s devices are Class IIb and Class II. Each device page shows its own class and authorisation.
What are the newest devices from MEZOO Co., Ltd. in the registry?
The most recently registered devices listed for MEZOO Co., Ltd. include Wearable ECG & Arrhythmia diagnosis and monitor and HiCardi+ H100.