Gemss Healthcare Co., Ltd.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000031254 FEI 3030089787
- Devices
- 7
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Gemss Healthcare Co., Ltd. makes
GEMSS Healthcare Co., Ltd. manufactures X-ray imaging systems, including the XVISION-525, HORIZON, and HI-series (HI-300, HI-500) for general radiography, as well as the SATURN-F PF series (PF32, PF40, PF50) for fluoroscopy. The XPLUS 35 Series (XPLUS 35, XPLUS 35FD) provides portable or fixed digital X-ray solutions for various clinical settings.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company’s products are authorised for use in the United States, where the manufacturer is based.
Catalogue
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Registry: GUDID
Xlite Ref K260236
Regimes: 510(k) Registry: 510(k)Xvision-525 Ref XCO-CL-001
Regimes: CE MDR Registry: EUDAMEDGUDID- Regimes: 510(k) Registry: 510(k)
XPLUS 35 Series (XPLUS 35, XPLUS 35FD) Ref K233200
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- KR-MF-000031254
- FDA FEI number
- 3030089787
- DUNS number
- 694184465
- EU VAT number
- 1098645216
- EUDAMED status
- Active
- EUDAMED registered name
- GEMSS HEALTHCARE CO., LTD.
- EUDAMED abbreviated name
- GEMSS
- Registered address
- 822, Bogwang-ro, Gwangtan-myeon, Paju-si,, 10952, Gyeonggi-do, South Korea
- Website
- www.gemss-healthcare.com
- [email protected]
- Phone
- +82 31 906 9017
- PRRC contact
- Jiho Park
Frequently asked questions
How many devices does GEMSS HEALTHCARE CO., LTD. have in the registry?
The registry currently lists 7 devices for GEMSS HEALTHCARE CO., LTD.. Devices recorded under merged duplicate company entries are counted once.
Which registries list GEMSS HEALTHCARE CO., LTD.'s devices?
Among its 7 most recently registered devices, GEMSS HEALTHCARE CO., LTD. has devices listed in EUDAMED (3 devices), FDA 510(k) (3 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do GEMSS HEALTHCARE CO., LTD.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for GEMSS HEALTHCARE 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 GEMSS HEALTHCARE CO., LTD. in the registry?
The most recently registered devices listed for GEMSS HEALTHCARE CO., LTD. include XPLUS 35 Series XPLUS 35FD, XPLUS 35 Series, XLITE and XVISION-525.