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BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer
FDA UDIIdentity
- Trade Name
- BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care FDA UDI
- Device Name
- A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemoglobin concentration as anaid to monitor the risk of developing diabetes and control the status of diabetes.The HbA1c analyzer is specifically designed to be used with the corresponding test strip. FDA UDI
- Model / Reference
- A1C EZ 2.0 FDA UDI
- Description
- A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemoglobin concentration as anaid to monitor the risk of developing diabetes and control the status of diabetes.The HbA1c analyzer is specifically designed to be used with the corresponding test strip. FDA UDI
Identifiers
- Catalog Number
- A1C-M21 FDA UDI
- Primary DI / UDI-DI
- 06935784400019 FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care FDA UDI
Classification
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
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Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
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Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — FDA UDI — listed in FDA GUDID
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Sources (1)
- FDA UDI be0845eb-8729-43a2-a5a6-5b10951ce3b3 35 fields · synced May 30, 2026