OK Medinet Korea Co., Ltd.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED SRN KR-MF-000033858
- Devices
- 2
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What OK Medinet Korea Co., Ltd. makes
OK Medinet Korea Co., Ltd. manufactures the Kyphoplasty Balloon System, a device used for vertebral augmentation to treat fractures, particularly in the spine.
The Kyphoplasty Balloon System is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
- CE MDD EUDAMED
Kyphoplasty Balloon System Ref K221142
510(k) 510(k)
Company details
- EUDAMED SRN
- KR-MF-000033858
- EU VAT number
- 105-86-37941
- EUDAMED status
- Active
- EUDAMED registered name
- OK Medinet Korea
- Registered address
- 130, Geumcheon-gu, Digital-ro, 08589, Seoul, South Korea
- Website
- okmk1.com/
- [email protected]
- Phone
- +821057224489
- PRRC contact
- Eui-gyo Jung
Frequently asked questions
How many devices does OK Medinet Korea Co., Ltd. have in the registry?
The registry currently lists 2 devices for OK Medinet Korea Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list OK Medinet Korea Co., Ltd.'s devices?
Among its 2 most recently registered devices, OK Medinet Korea 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 OK Medinet Korea Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for OK Medinet Korea Co., Ltd.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from OK Medinet Korea Co., Ltd. in the registry?
The most recently registered devices listed for OK Medinet Korea Co., Ltd. include KYBS Kyphoplasty Balloon System and Kyphoplasty Balloon System.