BioHermes Automated Glycohemoglobin Analyzer
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- BioHermes Automated Glycohemoglobin Analyzer FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1C) analyser IVD FDA UDI
- Device Name
- Automated Glycohemoglobin Analyzer EUDAMEDThe BH60 Automated Glycohemoglobin Analyzer is intended for in vitro diagnostic use for the quantitative measurement of HbA1c in whole blood specimens in combination with Glycohemoglobin Analytical Column and Glycohemoglobin Reagent Kit produced by Wuxi Biohermes Bio & Medical Technology Co., Ltd. using ion-exchange high-performance liquid chromatography (HPLC). FDA UDI
- Model / Reference
- BH60 EUDAMEDFDA UDIHP-M51 EUDAMED
- Description
- The BH60 Automated Glycohemoglobin Analyzer is intended for in vitro diagnostic use for the quantitative measurement of HbA1c in whole blood specimens in combination with Glycohemoglobin Analytical Column and Glycohemoglobin Reagent Kit produced by Wuxi Biohermes Bio & Medical Technology Co., Ltd. using ion-exchange high-performance liquid chromatography (HPLC). FDA UDI
Identifiers
- Catalog Number
- HP-M51 FDA UDI
- Primary DI / UDI-DI
- 06935784430016 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06935784430016 EUDAMED
- FDA Product Code
- PDJ FDA UDI
- EMDN Code
- W0201060101 GLYCOSILATED HEMOGLOBIN DEVICES EUDAMED
- GMDN Term
- Glycated haemoglobin (HbA1C) analyser IVD FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1373 FDA UDI
- 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
No
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) analyser IVD
BioHermes Automated Glycohemoglobin Analyzer by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — Class II — 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 | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Sources (2)
- FDA UDI 76866856-0cda-4f46-8e09-9db9cb2a5195 34 fields · synced Jul 17, 2026
- EUDAMED f6cec7a6-5e01-41f0-9507-26051c0c69ef 61 fields · synced Jul 17, 2026