Hansung Co., Ltd
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000047019
- Devices
- 4
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
Catalogue
Apollon 2330V, Ref HMC-AP2330-001
Regimes: CE MDR Registry: EUDAMEDApollon 2350V Ref HMC-AP2350-001
Regimes: CE MDR Registry: EUDAMEDApollon 2318V Ref HMC-AP2318-001
Regimes: CE MDR Registry: EUDAMEDApollon 2322V Ref HMC-AP2322-001
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- KR-MF-000047019
- EU VAT number
- 6928702981
- EUDAMED status
- Active
- EUDAMED registered name
- HANSUNG CO.,LTD
- Registered address
- 40-11, 2 GONGDAN 4 RO, 31074, CHEONAN SI, CHUNGCHEONGNAM DO, South Korea
- Website
- www.hsclave.com
- [email protected]
- Phone
- +82 41 5378140
- PRRC contact
- SEONG HO SON
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 2 Aug 2031
UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292 1 certificate
- MDR.2292-2026/0052 Active
Quality management system EU MDR
- Issued
- 3 Aug 2026
- Expires
- 2 Aug 2031
FDA establishments
- Hansung Company Gimpo-si Gyeonggi · KR FEI 3011484062
Frequently asked questions
How many devices does HANSUNG CO.,LTD have in the registry?
The registry currently lists 4 devices for HANSUNG CO.,LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list HANSUNG CO.,LTD's devices?
Among its 4 most recently registered devices, HANSUNG CO.,LTD has devices listed in EUDAMED (4 devices).
What risk classes do HANSUNG CO.,LTD's devices fall under?
Among its 4 most recently registered devices, the classes recorded for HANSUNG CO.,LTD's devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for HANSUNG CO.,LTD?
EUDAMED lists 1 certificate for HANSUNG CO.,LTD (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 3 Aug 2026.
What are the newest devices from HANSUNG CO.,LTD in the registry?
The most recently registered devices listed for HANSUNG CO.,LTD include APOLLON 2330V,, APOLLON 2350V, APOLLON 2318V and APOLLON 2322V.
Which FDA establishments are linked to HANSUNG CO.,LTD?
1 FDA establishment is linked to HANSUNG CO.,LTD in the registry; they are listed on the company page.