Company profile
Abbott Korea Diagnostics
KO: (주)한국애보트진단
South Korea·경기도 용인시 기흥구 하갈로15번길 46 (보라동)·270 devices·Registered Feb 05, 2014 – Oct 31, 2023270
Total devices
5
Device classes
Feb 05, 2014
Earliest approval
Oct 31, 2023
Latest approval
Device class distribution
Breakdown of 270 devices by regulatory classification
Unknown
224
83.0% of total
Class III
20
7.4% of total
Class II
15
5.6% of total
Class I
10
3.7% of total
Class IV
1
0.4% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
| Device Name | Class | License Number | Approval Date |
|---|---|---|---|
| High-risk infection immunoassay reagent 고위험성감염체면역검사시약 | Unknown | In Vitro Drug No. 23-1018 | Oct 31, 2023 |
| High-risk infection immunoassay reagent 고위험성감염체면역검사시약 | Unknown | In Vitro No. 23-906 | Sep 11, 2023 |
| Disposable Automatic Lancet 일회용자동랜싯 | Unknown | Suin 23-4614 | Jun 07, 2023 |
| Disposable manual lancet 일회용수동랜싯 | Unknown | Suin 23-4616 | Jun 07, 2023 |
| Capillary blood collection tube 모세관채혈튜브 | Unknown | Reception No. 23-494 | Mar 08, 2023 |
| High-risk infection immunoassay reagent 고위험성감염체면역검사시약 | Class III | In Vitro Formulation No. 23-39 | Jan 18, 2023 |
| Infectious agent diagnostic immunoassay reagent 감염체 진단 면역검사시약 | Unknown | In Vitro No. 22-507 | Jul 29, 2022 |
| High-risk infection immunoassay reagent 고위험성감염체면역검사시약 | Unknown | In Vitro No. 22-291 | May 06, 2022 |
| High-risk infection immunoassay reagent 고위험성감염체면역검사시약 | Unknown | In Vitro No. 22-114 | Feb 18, 2022 |
| High-risk infection immunoassay reagent 고위험성감염체면역검사시약 | Unknown | In Vitro No. 22-4 | Jan 06, 2022 |
About this profile
Complete regulatory portfolio for Abbott Korea Diagnostics in South Korea's medical device market. This company has 270 medical devices registered with South Korea MFDS, with registrations dating from Feb 05, 2014 to Oct 31, 2023.
Browse the complete device portfolio including device classifications, license numbers, approval dates, and technical specifications. Pure Global AI provides free access to comprehensive South Korea MFDS registration data, helping global MedTech companies analyze market presence and regulatory compliance for medical device manufacturers in South Korea.
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