Is this your brand? Sign in to claim ownership.
Sign in to claim this brandOMNIS HEALTH, LLC
US
Last updated May 23, 2026
What OMNIS HEALTH, LLC makes
The company manufactures single-use blood lancets for home or point-of-care glucose monitoring, along with autoinjector needles designed for insulin delivery. It also produces blood glucose test strips in various pack sizes, including refill bundles for gestational diabetes, as well as all-in-one blood glucose monitoring systems combining meters, strips, and control solutions. Additional offerings include standalone glucose meters and pre-assembled meter kits with test strips.
These devices are classified under FDA regulations as Class I and Class II medical instruments, with most entries listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates within the United States, adhering to domestic regulatory requirements for in vitro diagnostics (IVDs) and reusable/non-reusable sharps.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 824763358
Catalogue (61)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Embrace Pro Strips, 50-ct vials | ALL02AB0202 | FDA UDI | Class II | Active |
| Embrace TALK Blood Glucose Monitor | APX03AB0300 | FDA UDI | Class II | Active |
| Embrace Pro Meter | ALL01AB0200 | FDA UDI | Class II | Active |
| EmbraceWAVE Blood Glucose Test Strips 100 ct. | APX04AB0405 | FDA UDI | Class II | Active |
| EmbraceWAVE+ Blood Glucose Monitoring System Starter Kit | APX04AB0401BT | FDA UDI | Class II | Active |
| Embrace Control Solution, L2 (High) | APX02AB0311 | FDA UDI | Class I | Active |
| Embrace Gestational Diabetes Package - RETAIL (5 vials) | APX02GS0202RF | FDA UDI | Class II | Active |
| Embrace Pro Control Solution (L1/Normal; L2/High) | ALL02AB0210 | FDA UDI | Class I | Active |
| Embrace Control Solution Low | APX02AB0510 | FDA UDI | Class II | Active |
| Embrace Strips, 50ct Vial - Distributor partner | APX02AB0202 | FDA UDI | Class II | Active |
| Embrace Pen Needle 31G @5mm | SHN02MM31.05 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.