| Primary Device ID | 27506555400014 |
| NIH Device Record Key | e38e1b32-ae0c-472f-a4b3-8087f64859ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Glucheck Blood Glucose Test Strip |
| Version Model Number | EM44 |
| Company DUNS | 658620117 |
| Company Name | EPS BIO TECHNOLOGY CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07506555400010 [Primary] |
| GS1 | 27506555400014 [Package] Contains: 07506555400010 Package: carton [150 Units] In Commercial Distribution |
| NBW | System, Test, Blood Glucose, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-12 |
| Device Publish Date | 2026-01-02 |
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| 10885017000550 - EasyMax NHCS Set EN | 2020-07-01 1 bottle of Level 2 Solution |
| 10885017000567 - EasyMax 15 NHCS Set EN | 2020-07-01 a bottle of level 2 control solution |