BioHermes A1cChek Pro Glycohemoglobin Analyzer
FDA UDIEUDAMEDIdentity
- Trade Name
- BioHermes A1cChek Pro Glycohemoglobin Analyzer FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care FDA UDI
- Device Name
- A1cChek Pro Glycohemoglobin Analyzer EUDAMEDGlycohemoglobin Analyzer EUDAMEDA1cChek Pro Glycohemoglobin Analysis System is intended for the percent determination of Hemoglobin A1c in human whole blood using boronate affinity chromatography. A1cChek Pro Glycohemoglobin Analyzer is intended for Professional Use Only. For In Vitro Diagnostic Use Only. FDA UDI
- Model / Reference
- A1C EZ Auto 4 W EUDAMEDFDA UDIA1C-M31 EUDAMEDA1C EZ 2.0 BT EUDAMEDA1C-M22 EUDAMED
- Description
- A1cChek Pro Glycohemoglobin Analysis System is intended for the percent determination of Hemoglobin A1c in human whole blood using boronate affinity chromatography. A1cChek Pro Glycohemoglobin Analyzer is intended for Professional Use Only. For In Vitro Diagnostic Use Only. FDA UDI
Identifiers
- Catalog Number
- A1C-M31 FDA UDI
- Primary DI / UDI-DI
- 06935784400026 EUDAMEDFDA UDI06935784410018 EUDAMED
- Basic UDI-DI
- B-06935784400026 EUDAMEDB-06935784410018 EUDAMED
- EMDN Code
- W0201060101 GLYCOSILATED HEMOGLOBIN DEVICES EUDAMED
- GMDN Term
- Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass IVD devices for self-testing EUDAMED
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
Yes
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
Yes
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care
BioHermes A1cChek Pro Glycohemoglobin Analyzer by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | N/A | Unknown |
| 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 (3)
- FDA UDI 213076e3-fa8b-43a4-822d-4bed37d85b9f 34 fields · synced Sep 18, 2026
- EUDAMED 1e5c5244-1f79-4506-9be2-2cf5cf88f484 61 fields · synced Jul 9, 2026
- EUDAMED ea38490e-48f0-4b75-b21b-50d2e9523a65 61 fields · synced Sep 18, 2026