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GENOSS CO., Ltd.

Active in EUDAMED

South Koreafrom SRN EUDAMED FDA SRN KR-MF-000029064 FEI 3006223010

GENOSS CO., Ltd. is a medical device manufacturer based in South Korea, with 32 devices listed in FDA 510(k) and EUDAMED (FDA Class II and I; EU Class III) as of 14 Nov 2026.

Devices
32
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA 510(k) 18
  • EUDAMED 14

A device listed in two registries counts in both.

Device classes
  • FDA Class II 17
  • EU Class III 14
  • FDA Class I 1
Sites and related companies
Identifiers
  • EUDAMED SRN KR-MF-000029064
  • FDA FEI 3006223010
  • DUNS 690083006

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment
Authorised rep.
Emergo Europe B.V.NL

What GENOSS CO., Ltd. makes

GENOSS Co., Ltd. manufactures a range of medical devices including the Earloon Eustachian Tube Dilation System for ear procedures, dermal filler products such as Brifill (Ultra and Mild), INFINI PREMIUM FILLER (Soft Lip+), Hyalmass (SOFT), and CARA Filler (Soft), as well as aesthetic skin‑tightening solutions like Clearskin Lab (LIFT) and exquiller (SUB‑Q).

The company's portfolio spans Class I, Class II, and Class III devices and is listed in the European EUDAMED database and the U.S. FDA 510(k) registry; GENOSS is based in South Korea.

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue32

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Rows 1-32 of 32

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
KR-MF-000029064
FDA FEI number
3006223010
DUNS number
690083006
EUDAMED status
Active
EUDAMED registered name
GENOSS Co., Ltd.
Registered address
12F, 76, Changnyong-daero 256beon-gil, 16229, Suwon-si, Gyeonggi-do, South Korea
Phone
+82-70-7098-8938
PRRC contact
Ju Yun(public in EUDAMED)

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Genoss KR

Frequently asked questions

How many devices does GENOSS CO., Ltd. have in the registry?

The registry currently lists 32 devices for GENOSS CO., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list GENOSS CO., Ltd.'s devices?

Among its 32 most recently registered devices, GENOSS CO., Ltd. has devices listed in EUDAMED (14 devices) and FDA 510(k) (18 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do GENOSS CO., Ltd.'s devices fall under?

Among its 32 most recently registered devices, the classes recorded for GENOSS CO., Ltd.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.

What are the newest devices from GENOSS CO., Ltd. in the registry?

The most recently registered devices listed for GENOSS CO., Ltd. include Initiator Angiographic Catheter, GENOSS DES Sirolimus Eluting Coronary Stent System, GENOSS PTCA Balloon Catheter and DIVES MED ULTRA LIDOCAINE.

Which FDA establishments are linked to GENOSS CO., Ltd.?

1 FDA establishment is linked to GENOSS CO., Ltd. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.