DFI Co., Ltd.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED SRN KR-MF-000015786
DFI Co., Ltd. is a medical device manufacturer based in South Korea, with 98 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class B, Class A and IVD General; FDA Class I) and 7 FDA recalls as of 13 Nov 2026.
- Devices
- 98
- Registrations
- EUDAMED
- FDA recalls
- 77 ongoing
Registry facts
- Registries
- EUDAMED 81
- FDA GUDID 21
- FDA 510(k) 4
- Device classes
- EU Class B 39
- EU Class A 18
- FDA Class I 18
- EU IVD General 9
- EU IVD devices for self-testing 7
- FDA Class II 5
- Top EMDN categories
- Reagents 54
- IVD instruments 19
- FDA recalls
- Sites and related companies
- MDSS GmbH authorised representative
- Identifiers
- EUDAMED SRN KR-MF-000015786
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA recalls
- Authorised rep.
- MDSS GmbHDE
Catalogue
Search and filter all 98 devicesShowing 1-50 of 98
Company details
- EUDAMED SRN
- KR-MF-000015786
- EU VAT number
- 6228114206
- EUDAMED status
- Active
- EUDAMED registered name
- DFI Co.,Ltd.
- Registered address
- 388-25, Gomo-ro, Jillye-myeon, 50875, Gimhae-si, South Korea
- dfira@dficare.com
- PRRC contact
- YONGAE PARK
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 29 Jun 2028
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HX 2028254-1 Active
Quality management system EU IVDR
- Issued
- 30 Jun 2023
- Expires
- 29 Jun 2028
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 7
2026
- 2 Apr 2026 Z-2082-2026 Class II Ongoing The devices were distributed without required FDA premarket clearance or approval.
- 2 Apr 2026 Z-2083-2026 Class II Ongoing The devices were distributed without required FDA premarket clearance or approval.
- 2 Apr 2026 Z-2084-2026 Class II Ongoing The devices were distributed without required FDA premarket clearance or approval.
- 2 Apr 2026 Z-2085-2026 Class II Ongoing The devices were distributed without required FDA premarket clearance or approval.
- 2 Apr 2026 Z-2086-2026 Class II Ongoing The devices were distributed without required FDA premarket clearance or approval.
- 2 Apr 2026 Z-2087-2026 Class II Ongoing The devices were distributed without required FDA premarket clearance or approval.
- 2 Apr 2026 Z-2088-2026 Class II Ongoing The devices were distributed without required FDA premarket clearance or approval.
Frequently asked questions
How many devices does DFI Co.,Ltd. have in the registry?
The registry currently lists 98 devices for DFI Co.,Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list DFI Co.,Ltd.'s devices?
Among its 50 most recently registered devices, DFI Co.,Ltd. has devices listed in EUDAMED (50 devices).
What risk classes do DFI Co.,Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for DFI Co.,Ltd.'s devices are IVDR Class A, IVDR Class B, IVD general and IVD devices for self-testing. Each device page shows its own class and authorisation.
Are there FDA recall records for DFI Co.,Ltd.?
FDA recall records list 7 recalls initiated by DFI Co.,Ltd., the most recent initiated on 2 Apr 2026. 7 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for DFI Co.,Ltd.?
EUDAMED lists 1 certificate for DFI Co.,Ltd. (quality management system) under IVDR. 1 is recorded with the status issued. The most recent was issued on 30 Jun 2023.
What are the newest devices from DFI Co.,Ltd. in the registry?
The most recently registered devices listed for DFI Co.,Ltd. include DUS 8SG, ComboStik 11, UriDoctor 11 and CTBOW Reader 300.