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BioHermes Glycohemoglobin Analytical Column
FDA UDIEUDAMEDRef HP-Z112Model BH-CC12Ref HP-Z113Model BH-CC13Ref HP-Z111Model BH-CC11
Identity
- Trade Name
- BioHermes Glycohemoglobin Analytical Column FDA UDI
- Generic Name
- High performance liquid chromatography analyser column IVD FDA UDI
- Device Name
- Glycohemoglobin Analytical Column EUDAMEDGlycohemoglobin Analytical Column 1 pcs/kit (1000 tests) The Glycohemoglobin Analytical Column is intended to be used with the BH60 Automated Glycohemoglobin Analyzer, which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to separate glycohemoglobin (HbA1c) from human whole blood. FDA UDIGlycohemoglobin Analytical Column 1 pcs/kit (2000 tests) The Glycohemoglobin Analytical Column is intended to be used with the BH60 Automated Glycohemoglobin Analyzer, which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to separate glycohemoglobin (HbA1c) from human whole blood. FDA UDIGlycohemoglobin Analytical Column 1 pcs/kit (500 tests) The Glycohemoglobin Analytical Column is intended to be used with the BH60 Automated Glycohemoglobin Analyzer, which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to separate glycohemoglobin (HbA1c) from human whole blood. FDA UDI
- Model / Reference
- BH-CC12 EUDAMEDFDA UDIBH-CC13 EUDAMEDFDA UDIBH-CC11 EUDAMEDFDA UDIHP-Z112 EUDAMEDHP-Z113 EUDAMEDHP-Z111 EUDAMED
- Description
- Glycohemoglobin Analytical Column 1 pcs/kit (1000 tests) The Glycohemoglobin Analytical Column is intended to be used with the BH60 Automated Glycohemoglobin Analyzer, which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to separate glycohemoglobin (HbA1c) from human whole blood. FDA UDIGlycohemoglobin Analytical Column 1 pcs/kit (2000 tests) The Glycohemoglobin Analytical Column is intended to be used with the BH60 Automated Glycohemoglobin Analyzer, which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to separate glycohemoglobin (HbA1c) from human whole blood. FDA UDIGlycohemoglobin Analytical Column 1 pcs/kit (500 tests) The Glycohemoglobin Analytical Column is intended to be used with the BH60 Automated Glycohemoglobin Analyzer, which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to separate glycohemoglobin (HbA1c) from human whole blood. FDA UDI
Identifiers
- Catalog Number
- HP-Z112 FDA UDIHP-Z113 FDA UDIHP-Z111 FDA UDI
- Primary DI / UDI-DI
- 06935784430122 EUDAMEDFDA UDI06935784430139 EUDAMEDFDA UDI06935784430115 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06935784430122 EUDAMEDB-06935784430139 EUDAMEDB-06935784430115 EUDAMED
- EMDN Code
- W0201050285 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - CONSUMABLES EUDAMED
- GMDN Term
- High performance liquid chromatography analyser column IVD 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: High performance liquid chromatography analyser column IVD
BioHermes Glycohemoglobin Analytical Column 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 (6)
- FDA UDI a6214a9c-672f-46e4-b4ae-7635d50775f5 34 fields · synced Aug 2, 2026
- FDA UDI f9430acd-84fe-49e3-85bd-7908c8e83dfa 34 fields · synced May 30, 2026
- FDA UDI a4de8637-1ffa-4104-a26d-f25fcf20b92d 34 fields · synced May 30, 2026
- EUDAMED 9c5a8eb8-7c06-4dd4-8929-80baa1cda04c 61 fields · synced Jul 15, 2026
- EUDAMED c82cf764-af34-4394-b2f1-a61ff473b370 61 fields · synced Jul 21, 2026
- EUDAMED a0e69c3c-735b-4f75-9ed7-0ce78af72b7f 61 fields · synced Aug 2, 2026