Identity
- Trade Name
- 25 EasyMax 15 FTS Set EN-ES FDA UDI
- Generic Name
- Glucose IVD, kit, enzyme spectrophotometry, rapid FDA UDI
- Device Name
- The EASY MAX 15 Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. The test Strips must be used with the EASY MAX 15 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, is not for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can only be used during steady-state blood glucose conditions. FDA UDI
- Model / Reference
- EASY MAX 15 FDA UDI
- Description
- The EASY MAX 15 Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. The test Strips must be used with the EASY MAX 15 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, is not for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can only be used during steady-state blood glucose conditions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885017000287 FDA UDI
- 510(k) Number
- K112272 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Glucose IVD, kit, enzyme spectrophotometry, rapid FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glucose IVD, kit, enzyme spectrophotometry, rapid
25 EasyMax 15 FTS Set EN-ES by Eps Bio Technology Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K112272 also covers:
- EM 15 Blood Glucose Level 1 Control Solution — EPS BIO TECHNOLOGY CORP.
- EM 15 Blood Glucose Level 1 and Level 2 Control Solution — EPS BIO TECHNOLOGY CORP.
- EM 15 Blood Glucose Level 2 Control Solution — EPS BIO TECHNOLOGY CORP.
- EasyMax 15 Blood Glucose Test Strip — EPS BIO TECHNOLOGY CORP.
- EasyMax 15 Blood Glucose Test Strip — EPS BIO TECHNOLOGY CORP.
- EasyMax 15 NHCS Set EN — EPS BIO TECHNOLOGY CORP.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Eps Bio Technology Corp.
Sources (1)
- FDA UDI 2c745523-3328-434e-aae9-8fa3abe2cf39 36 fields · synced May 30, 2026