Identity
- Trade Name
- EasyMax 15 Blood Glucose Test Strip FDA UDI
- Generic Name
- Glucose IVD, kit, enzyme spectrophotometry, rapid FDA UDI
- Device Name
- 50 strips in a vial FDA UDI
- Model / Reference
- EM44 FDA UDI
- Description
- 50 strips in a vial FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885017000416 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
No
FDA UDI
Category: Glucose IVD, kit, enzyme spectrophotometry, rapid
EasyMax 15 Blood Glucose Test Strip by Eps Bio Technology Corp. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Glucose IVD, kit, enzyme spectrophotometry, rapid.
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Cleared under the same submission
K112272 also covers:
- 25 EasyMax 15 FTS Set EN-ES — EPS BIO TECHNOLOGY CORP.
- 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 NHCS Set EN — EPS BIO TECHNOLOGY CORP.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Eps Bio Technology Corp.
Sources (2)
- FDA UDI fb699a20-884d-4fb9-9eda-fd30d41f8578 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 29, 2026