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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
- 06935784410001 FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care FDA UDI
Classification
- Commercial Distribution
- 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
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care
BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — FDA UDI — listed in FDA GUDID
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- BioHermes A1cChek Pro Glycohemoglobin Analyzer — Wuxi Biohermes Bio & Medical Technology Co., Ltd.
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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 385eba8a-9931-4e4b-948a-b24d2da24e1a 34 fields · synced May 30, 2026