Identity
- Trade Name
- BioHermes Glycohemoglobin Calibrator FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, calibrator FDA UDI
- Device Name
- Glycohemoglobin Calibrator EUDAMEDThe Glycohemoglobin Calibrator is intended to be used as the calibration for glycohemoglobin analysis systems (the BH60 Automated Glycohemoglobin Analyzer and glycohemoglobin reagent kit) with the methodology of ion-exchange high-performance liquid chromatography (HPLC), manufactured by Wuxi BioHermes Bio & Medical Technology Co., Ltd.. Contents: 5x Level 1 (1mL), 5 x Level 2 (1mL). FDA UDI
- Model / Reference
- BH-CA01 EUDAMEDFDA UDIHP-CA122 EUDAMED
- Description
- The Glycohemoglobin Calibrator is intended to be used as the calibration for glycohemoglobin analysis systems (the BH60 Automated Glycohemoglobin Analyzer and glycohemoglobin reagent kit) with the methodology of ion-exchange high-performance liquid chromatography (HPLC), manufactured by Wuxi BioHermes Bio & Medical Technology Co., Ltd.. Contents: 5x Level 1 (1mL), 5 x Level 2 (1mL). FDA UDI
Identifiers
- Catalog Number
- HP-CA122 FDA UDI
- Primary DI / UDI-DI
- 06935784430528 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06935784430528 EUDAMED
- EMDN Code
- W0101050302 CALIBRATORS SINGLE COMPONENT (CC) EUDAMED
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glycated haemoglobin (HbA1c) IVD, calibrator
BioHermes Glycohemoglobin Calibrator 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
European Union Unknown
IVDD
United States Pending data
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 (2)
- FDA UDI bcca1e25-bfcb-40cf-9739-f3af41627220 35 fields · synced Aug 2, 2026
- EUDAMED 132ee84e-6c12-44fd-b6aa-3684408a7203 61 fields · synced Aug 2, 2026