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BioHermes A1cChek Express Glycohemoglobin Analyzer
FDA UDIIdentity
- Trade Name
- BioHermes A1cChek Express Glycohemoglobin Analyzer FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care FDA UDI
- Device Name
- A1cChek Express Glycohemoglobin analyzer is for use with the A1cChek Express Glycohemoglobin Test Kit to quantitatively measure the HbA1c in human capillary blood or venous blood. FDA UDI
- Model / Reference
- A1C-EXP M12 FDA UDI
- Description
- A1cChek Express Glycohemoglobin analyzer is for use with the A1cChek Express Glycohemoglobin Test Kit to quantitatively measure the HbA1c in human capillary blood or venous blood. FDA UDI
Identifiers
- Catalog Number
- A1C-M41 FDA UDI
- Primary DI / UDI-DI
- 06935784411077 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 A1cChek Express Glycohemoglobin Analyzer by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — FDA UDI — listed in FDA GUDID
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Also classified as Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care.
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- BioHermes A1cChek Pro Glycohemoglobin Analyzer — Wuxi Biohermes Bio & Medical Technology Co., Ltd.
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- BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer — Wuxi Biohermes Bio & Medical Technology Co., Ltd.
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 999d3f3f-47d4-4405-9e1f-c9ede29d5718 34 fields · synced May 30, 2026