Data / Medical devices / South Korea / All Medicus Co., Ltd.
All Medicus Co., Ltd.: FDA-registered device maker in Anyang-si Gyeonggi, South Korea, 4 510(k) clearances
All Medicus Co., Ltd. is registered with the FDA (registration 3007363438) in Anyang-si Gyeonggi, South Korea. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 30, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007363438
- FEI number
- 3005664575
- Address
- No.7102-7107,7402,7403,7406, 140, Beolmal-ro Dongan-gu, Anyang-si Gyeonggi, South Korea, 14057
- Owner or operator
- All Medicus Co., Ltd (10027562)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 27, 2009
- Registered through
- 2026
- Brand names listed
- Alere G1 Blood Glucose Monitoring System, Embrace PRO Blood Glucose Monitoring System, Embrace PRO Blood Glucose Test Meter, Embrace PRO Blood Glucose Test Strips, Embrace PRO Control Solution, GLUCODR AUTO SYSTEM, Lancet, Lancing Device, Lancets and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Dehydrogenase, Glucose | LFR | 2 | Manufacturer | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Exporter to the US | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Exporter to the US | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Exporter to the US | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 30, 2022 | K221970 | Lancing device | QRL | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| July 6, 2022 | K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) | QRL | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| October 13, 2017 | K170241 | GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System | NBW | Substantially Equivalent | All Medicus Co., Ltd. | accessdata.fda.gov |
| May 1, 2009 | K083628 | GLUCODR AUTO SYSTEM | NBW | Substantially Equivalent | All Medicus Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Glucose Dehydrogenase, Glucose
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Updated August 30, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.