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Sign in to claim this brandAMVENTUREX, INC.
US
Last updated May 24, 2026
What AMVENTUREX, INC. makes
The company produces in vitro diagnostic (IVD) devices for home-use blood glucose and ketone monitoring, including test strips, meters, control solutions, and spectrophotometry-based ketone test kits. Products include standalone glucose meters, ketone test strips, and integrated systems combining glucose and ketone monitoring, as well as reagents and controls for accuracy verification.
These devices are classified under FDA’s In Vitro Diagnostic Device regulations, with most falling into Class I or Class II categories. They are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory compliance. The company operates from the United States, adhering to domestic IVD regulatory standards.
Written from this company's registered devices by an AI model, 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
- 117225590
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ketocoach Meter Only | S11007 | FDA UDI | Class I | Active |
| BIOCOACH Blood Glucose Test Strips 25s | S5640988 | FDA UDI | Class II | Active |
| KETOCOACH CONTROL SOLUTION Level 2 | S5800335 | FDA UDI | Class I | Active |
| BIOCOACH Blood Glucose Test Strips 50 Pack (Foil) | S5640936 | FDA UDI | Class II | Active |
| Ketocoach 50 Blood Ketone Test Strips | S5640791 | FDA UDI | Class I | Active |
| BIOCOACH Glucose Control Solution L1/L2 | S5800382 | FDA UDI | Class I | Active |
| BIOCOACH Blood Ketone Test Strips 50 Pack (Foil) | S5640934 | FDA UDI | Class I | Active |
| BIOCOACH Blood Glucose and Ketone Monitoring System | S84102 | FDA UDI | Class I | Active |
| Ketocoach Blood Ketone Meter | s11006 | FDA UDI | Class I | Active |
| BIOCOACH Blood Glucose Test Strips 50s | S5640989 | FDA UDI | Class II | Active |
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