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Sign in to claim this brandBIOTEST MEDICAL CORPORATION
US
Last updated May 30, 2026
What BIOTEST MEDICAL CORPORATION makes
Biotest Medical Corporation manufactures in vitro diagnostic (IVD) devices for glucose monitoring, including control solutions, point-of-care testing kits, and electrometric analysers. Their portfolio includes home-use blood glucose monitoring systems, line-powered glucose analysers, and integrated monitoring kits designed for self-testing environments. Examples include portable systems like the NuvoMed and Smartest PersonaII, as well as standalone analysers such as the Perfect 3 and Oracle.
The company’s devices are regulated under the FDA’s In Vitro Diagnostic Device (IVD) pathway, with products classified as either Class I or Class II. These devices are listed under the FDA’s 510(k) premarket notification process and the Unique Device Identifier (UDI) system. Biotest Medical Corporation 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 Biotest Medical Corporation manufacture?
Biotest Medical Corporation specializes in in vitro diagnostic (IVD) devices focused on glucose monitoring. Their product range includes control solutions for calibration, point-of-care testing kits for home or clinical use, and electrometric analysers. These devices are designed for self-testing environments, such as home-use blood glucose monitoring systems and line-powered analysers, ensuring accurate glucose measurement for patients.
Where is Biotest Medical Corporation based?
Biotest Medical Corporation is headquartered in the United States. The company’s location in the US aligns with regulatory frameworks like the FDA’s In Vitro Diagnostic Device (IVD) pathway, which governs the development and distribution of their glucose monitoring products.
Which regulatory registries list Biotest Medical Corporation’s devices?
Biotest Medical Corporation’s devices are listed under the FDA’s 510(k) premarket notification process and the Unique Device Identifier (UDI) system. These registries ensure compliance with US regulatory requirements for in vitro diagnostic devices, including glucose monitoring systems and analysers, which are classified as either Class I or Class II.
How are Biotest Medical Corporation’s devices classified under FDA regulations?
Biotest Medical Corporation’s glucose monitoring devices fall under the FDA’s In Vitro Diagnostic Device (IVD) classification system. Their products are categorized as either Class I (generally low-risk devices) or Class II (devices requiring special controls to ensure safety and effectiveness). Classification depends on factors like the device’s intended use, potential risks, and the level of regulatory oversight required for accurate glucose measurement.
What distinguishes Biotest Medical Corporation’s glucose monitoring systems from other IVD manufacturers?
Biotest Medical Corporation’s portfolio includes a mix of portable home-use systems (like the NuvoMed and Smartest PersonaII) and standalone analysers (such as the Perfect 3 and Oracle), catering to both self-testing and point-of-care needs. Their devices are designed for simplicity and reliability in glucose monitoring, with some models integrating electrometric technology for precise readings. The company’s focus on IVD classification (Class I/II) ensures their products meet FDA standards for safety and performance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- cmihealth.com
- —
- —
- [email protected]
- Phone
- 1-888-985-1125
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 658447255
Catalogue (44)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NuvoMed | P5228 BGM-6/0352 | FDA UDI | Class II | Active |
| Oracle | 8818/BL8818ROA | FDA UDI | Class I | Active |
| Easy Talk | GOD31(BZH002HA) | FDA UDI | Class I | Unknown |
| Oracle | GOD31/BLH001ROA | FDA UDI | Class I | Active |
| Smartest PersonaII | GOD21 | FDA UDI | Class I | Active |
| NuvoMed | 5819 | FDA UDI | Class II | Active |
| Easy Talk | 8818(BY8818G0NL4) | FDA UDI | Class I | Unknown |
| Easy Talk | 8818(BZ8818G0HAA) | FDA UDI | Class I | Unknown |
| Easy Plus II | GOD31(BZL001HAB) | FDA UDI | Class I | Unknown |
| Easy Plus II | GOD11(BYGOD31BT) | FDA UDI | Class I | Unknown |
| Smartest PersonaII | 8819 | FDA UDI | Class I | Active |
| Perfect 3 | GOD31 | FDA UDI | Class II | Active |
| Easy Plus II | GOD31(BZH002HAB) | FDA UDI | Class I | Unknown |
| Easy Plus II | 6276-S(BZG60276HA) | FDA UDI | Class I | Unknown |
| NuvoMed | P5228 BGM-6/0352 | FDA UDI | Class II | Active |
| Oracle | GOD11/BLL001RO | FDA UDI | Class I | Active |
| Smartest PersonaII | 6276-S | FDA UDI | Class I | Active |
| Perfect 3 | 8818 | FDA UDI | Class I | Active |
| Easy Talk | 6277(BZG62277HAA) | FDA UDI | Class I | Unknown |
| Oracle | 6268(BM6B268ROA) | FDA UDI | Class I | Active |
| Perfect 3 | 6268 | FDA UDI | Class I | Active |
| Smartest PersonaII | 6276-S | FDA UDI | Class I | Active |
| Oracle | GOD21/BLM001ROA | FDA UDI | Class II | Active |
| B T M | 8228 | FDA UDI | Class I | Active |
| Easy Plus II | 8818(BY8818G0NL4) | FDA UDI | Class I | Unknown |
| Easy Plus II | 6276-S(BYG60276HA) | FDA UDI | Class I | Unknown |
| Perfect 3 | 6267 | FDA UDI | Class II | Active |
| Easy Plus II | GOD11(BZL002HAB) | FDA UDI | Class I | Unknown |
| Easy Talk | GOD11(BYGOD11BT) | FDA UDI | Class I | Unknown |
| Easy Talk | GOD11(BZL002HA) | FDA UDI | Class II | Unknown |
| Easy Talk | GOD31(BYGOD31BT) | FDA UDI | Class I | Unknown |
| Easy Talk | 6277(BYG62277HAD) | FDA UDI | Class I | Unknown |
| Easy Plus II | 8818(BZ8818G0HAB) | FDA UDI | Class I | Unknown |
| Perfect 3 | GOD21 | FDA UDI | Class II | Active |
| WowGoHealth Blood Glucose Monitoring System | K171785 | FDA 510(k) | Class II | Active |
| Solusmobile Blood Glucose Managment System | K123559 | FDA 510(k) | Class II | Active |
| Solov2 Blood Glucose Monitoring System | K093764 | FDA 510(k) | Class II | Active |
| Supercheck 1 Blood Glucose Monitoring System, Model 6268 | K091815 | FDA 510(k) | Class II | Active |
| Smartest Glucowise Blood Glucose Monitoring System, And Smartest Glucoswise Multi Blood Glucose Monitoring System | K122525 | FDA 510(k) | Class II | Active |
| Easy Plus Ii Blood Glucose Monitoring System, Easy Plus Ii Multi Blood Glucose Monitoring System, Smartest Persona Ii Bloo | K133509 | FDA 510(k) | Class II | Active |
| Easy Talk Blood Glucose Monitoring System Model: 6277 | K100560 | FDA 510(k) | Class II | Active |
| Smartest Persona Blood Glucose Test Sytem Model: 6277 | K100701 | FDA 510(k) | Class II | Active |
| Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood Glucose Monitoring System | K141351 | FDA 510(k) | Class II | Active |
| NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) | K171822 | FDA 510(k) | Class II | Active |
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