Zerone Co., Ltd.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED SRN KR-MF-000014148
Zerone Co., Ltd. is a medical device manufacturer based in South Korea, with 29 devices listed in EUDAMED (EU Class IIb and IIa) as of 14 Nov 2026.
- Devices
- 29
- Registrations
- EUDAMED
Registry facts
- Registries
- EUDAMED 29
- Device classes
- EU Class IIb 21
- EU Class IIa 8
- Top EMDN categories
- Sites and related companies
- CMC Medical Devices & Drugs SL authorised representative
- Identifiers
- EUDAMED SRN KR-MF-000014148
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- CMC Medical Devices & Drugs SLES
What Zerone Co., Ltd. makes
Zerone Co., Ltd. manufactures electrosurgical devices, including sealed systems like the Vi-Sealer and standalone electrosurgical units, as well as ultrasonic surgical units for tissue dissection and coagulation. Their portfolio also includes syringe pumps and infusion pumps for precise medication delivery, alongside suction-irrigation pumps for surgical fluid management. Diagnostic tools such as ECG analysis systems are part of their offerings, catering to both intraoperative and monitoring needs.
The company’s devices are classified under EU regulations as Class IIa and Class IIb, indicating moderate to high risk, and are registered in the EU’s eudamed database. Zerone Co., Ltd. is based in South Korea and adheres to relevant regulatory frameworks for medical devices in that market.
Catalogue
Search and filter all 29 devicesCompany details
- EUDAMED SRN
- KR-MF-000014148
- EUDAMED status
- Active
- EUDAMED registered name
- Zerone Co., Ltd.
- Registered address
- (Shinil IT UTO Bldg., Dangjeong-dong) 8F, LS-ro 13, 15843, Gunpo-si, Gyeonggi-do, South Korea
- Website
- www.01zeus.com/
- overseas@01zeus.com
- Phone
- +82-31-453-3512
- PRRC contact
- Jeong Hwan Lee
Frequently asked questions
How many devices does Zerone Co., Ltd. have in the registry?
The registry currently lists 29 devices for Zerone Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zerone Co., Ltd.'s devices?
Among its 29 most recently registered devices, Zerone Co., Ltd. has devices listed in EUDAMED (29 devices).
What risk classes do Zerone Co., Ltd.'s devices fall under?
Among its 29 most recently registered devices, the classes recorded for Zerone Co., Ltd.'s devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.
What are the newest devices from Zerone Co., Ltd. in the registry?
The most recently registered devices listed for Zerone Co., Ltd. include Vi-Sealer, Electrosurgical Unit, Tropian and Syringe pump.