Genoss
Active in EUDAMEDSouth Koreafrom SRN EUDAMED SRN KR-MF-000029064
Part of GENOSS CO., Ltd.
Genoss is a medical device manufacturer based in South Korea, with 951 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (FDA Class II; EU Class III, IIa and I) as of 12 Nov 2026.
- Devices
- 951
- Registrations
- EUDAMED
Registry facts
- Registries
- EUDAMED 507
- FDA GUDID 440
- FDA 510(k) 5
- Device classes
- FDA Class II 429
- EU Class III 415
- EU Class IIa 87
- EU Class I 4
- FDA Class I 4
- Top EMDN categories
- Sites and related companies
- Identifiers
- EUDAMED SRN KR-MF-000029064
At a glance
Market reach
- European Union
- EUDAMED actor
What Genoss makes
Genoss manufactures ceramic materials for dental appliance fabrication, including pastes, stains, and shade blocks for custom dental restorations. Their portfolio also includes synthetic bone grafts for sinus augmentation, such as OSTEON II and OSTEON II Sinus, as well as collagen-based membranes for dental regeneration. Reusable medical devices include skin staple removers, catheter/overtube balloon inflators, and dental tools like implantation depth/angle gauges and cleaning brushes for dental prosthetics and orthodontic appliances. Additionally, they produce intracardiac electrodes for cardiac procedures.
Genoss devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. regulatory requirements for medical devices.
Catalogue
Search and filter all 951 devicesShowing 1-50 of 951
Company details
- EUDAMED SRN
- KR-MF-000029064
- EUDAMED status
- Active
- EUDAMED registered name
- GENOSS Co., Ltd.
- Registered address
- 12F, 76, Changnyong-daero 256beon-gil, 16229, Suwon-si, Gyeonggi-do, South Korea
- Website
- www.genoss.com
- wjpark@genoss.com
- Phone
- +82-70-7098-8938
- PRRC contact
- Ju Yun
Frequently asked questions
How many devices does Genoss have in the registry?
The registry currently lists 951 devices for Genoss. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genoss's devices?
Among its 50 most recently registered devices, Genoss has devices listed in EUDAMED (50 devices).
What risk classes do Genoss's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Genoss's devices are Class IIa and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Genoss in the registry?
The most recently registered devices listed for Genoss include Initiator Angiographic Catheter, GENOSS PTA balloon catheter, INFINI PREMIUM FILLER and INFINI PREMIUM FILLER SOFT LIPS.