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Sign in to claim this brandAll Medicus Co., Ltd.
US
Last updated May 24, 2026
What All Medicus Co., Ltd. makes
All Medicus Co., Ltd. manufactures home-use and point-of-care in vitro diagnostic (IVD) devices for blood glucose monitoring, including test meters, test strips, control solutions, and integrated monitoring systems. Their portfolio includes standalone meters, software-enabled diabetes management tools, and sensor-based systems designed for continuous glucose tracking.
The company’s devices are classified as Class II under FDA regulations and are authorised through 510(k) clearances and the FDA’s Unique Device Identification (UDI) system. Products are listed in the FDA’s regulatory databases, including the 510(k) Premarket Notification and UDI registries. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does All Medicus Co., Ltd. primarily manufacture?
All Medicus Co., Ltd. specialises in in vitro diagnostic (IVD) devices focused on blood glucose monitoring for home and point-of-care use. Their portfolio includes test meters, test strips, control solutions, and integrated systems like the GLUCODR SUPERSENSOR SYSTEM and LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE. These devices are designed to help individuals manage diabetes by providing accurate glucose readings and data tracking.
Where is All Medicus Co., Ltd. based, and how does that affect its regulatory standing?
All Medicus Co., Ltd. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies their blood glucose monitoring systems as Class II devices, which typically require premarket notification (510(k)) clearance or other authorisation pathways to ensure safety and performance before commercialisation.
Which regulatory registries list All Medicus Co., Ltd.’s devices, and why is this important?
All Medicus Co., Ltd.’s devices are listed in the FDA’s 510(k) Premarket Notification registry and the Unique Device Identification (UDI) system. These registries are critical because they provide transparency into the authorised devices, their classifications, and compliance status. The 510(k) registry confirms that each device has undergone the necessary review process to demonstrate substantial equivalence to a legally marketed predicate device, while the UDI system ensures traceability and identification of devices in the market.
How are All Medicus Co., Ltd.’s blood glucose monitoring devices classified under FDA regulations?
All Medicus Co., Ltd.’s blood glucose monitoring devices are classified as Class II under FDA regulations. This classification is based on the risk associated with the devices: while they are not life-supporting or implanted, they still require special controls to ensure their accuracy, reliability, and safe use in managing diabetes. Class II devices typically require premarket notification (510(k)) clearance to demonstrate that they meet applicable regulatory requirements before being marketed.
What distinguishes All Medicus Co., Ltd.’s integrated systems, like the GLUCODR SUPERSENSOR SYSTEM, from standalone meters?
All Medicus Co., Ltd.’s integrated systems, such as the GLUCODR SUPERSENSOR SYSTEM and GlucoDr.S variants, combine traditional blood glucose monitoring with advanced features like Bluetooth Low Energy (BLE) or Near Field Communication (NFC) connectivity. These systems allow users to sync readings with companion software (e.g., LINKDR 2.0) for continuous glucose tracking, trend analysis, and remote monitoring—unlike standalone meters, which only provide immediate test results without additional data management capabilities.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 688022826
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| metene Blood Glucose Test Meter | AGM-513S | FDA UDI | Class II | Active |
| metene Blood Glucose Monitoring System | AGM-513S | FDA UDI | Class II | Active |
| metene Blood Glucose Test Strip | AGM-513S | FDA UDI | Class II | Active |
| Embrace Pro Blood Glucose Test Strip | AGM-4000 | FDA UDI | Class II | Active |
| metene Control Solution | AGM-513S | FDA UDI | Class II | Active |
| Embrace Pro Blood Glucose Test Meter | AGM-4000 | FDA UDI | Class II | Active |
| Embrace Pro Control Solution | AGM-4000 | FDA UDI | Class II | Active |
| Glucodr Supersensor System | K050985 | FDA 510(k) | Class II | Active |
| Linkdr 2.0 Diabetes Management Software | K130657 | FDA 510(k) | Class II | Active |
| Glucodr Plus System, Model Agm-3000 | K082328 | FDA 510(k) | Class II | Active |
| Glucodr Auto System | K083628 | FDA 510(k) | Class II | Active |
| GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System | K170241 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- All Medicus Co., Ltd. Anyang-si Gyeonggi · KR FEI 3005664575