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BioHermes GluCoA1c Blood Glucose and Glycohemoglobin Analyzer
FDA UDIEUDAMEDRef GCA-M31Model GLU-A1C M12Ref GCA-M32Model GLU-A1C M14Ref GCA-M41Model GLU-A1C M22Ref GCA-M42Model GLU-A1C M24
Identity
- Trade Name
- BioHermes GluCoA1c Blood Glucose and Glycohemoglobin Analyzer FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care FDA UDI
- Device Name
- GluCoA1c Blood Glucose and Glycohemoglobin Analyzer EUDAMEDGluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use with GluCoA1c Glycohemoglobin Test Kit and GluCoA1c Blood Glucose Test Strips to quantitatively measure the HbA1c in human capillary blood or venous blood,and the blood glucose in human capillary blood. FDA UDI
- Model / Reference
- GLU-A1C M12 EUDAMEDFDA UDIGLU-A1C M22 EUDAMEDFDA UDIGLU-A1C M14 EUDAMEDFDA UDIGLU-A1C M24 EUDAMEDFDA UDIGCA-M31 EUDAMEDGCA-M32 EUDAMEDGCA-M41 EUDAMEDGCA-M42 EUDAMED
- Description
- GluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use with GluCoA1c Glycohemoglobin Test Kit and GluCoA1c Blood Glucose Test Strips to quantitatively measure the HbA1c in human capillary blood or venous blood,and the blood glucose in human capillary blood. FDA UDI
Identifiers
- Catalog Number
- GCA-M31 FDA UDIGCA-M41 FDA UDI
- Primary DI / UDI-DI
- 06935784420239 EUDAMEDFDA UDI06935784420246 EUDAMEDFDA UDI06935784420253 EUDAMEDFDA UDI06935784420260 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06935784420239 EUDAMEDB-06935784420253 EUDAMEDB-06935784420246 EUDAMEDB-06935784420260 EUDAMED
- EMDN Code
- W020106019099 VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care FDA UDI
Classification
- Device Class
- Class IVD devices for self-testing 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
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
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: Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care
BioHermes GluCoA1c Blood Glucose and Glycohemoglobin Analyzer by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — IVDD, FDA UDI — listed in FDA GUDID…
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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 (8)
- FDA UDI 0822dc36-a02b-48a5-8a95-b0ea52f13b87 34 fields · synced Aug 1, 2026
- FDA UDI 14b1a777-1f56-4e28-befb-fad191118f13 34 fields · synced May 30, 2026
- FDA UDI 1284fc52-bb36-46cc-b39d-dbd5c3ed38e3 34 fields · synced May 30, 2026
- FDA UDI 96f10d1b-8097-44d5-8e24-1163f15e4a0e 34 fields · synced May 30, 2026
- EUDAMED 9f01e22a-2eb9-4be1-aed5-2a40f61f2a20 61 fields · synced Jul 12, 2026
- EUDAMED c8b5def0-d0da-4ef9-9a2a-9c0add94d324 61 fields · synced Jul 12, 2026
- EUDAMED 216b344e-2317-4e57-9bb8-8a273bf54d8f 61 fields · synced Jul 16, 2026
- EUDAMED 9f1539f7-a6ad-469f-a020-972b705d9c98 61 fields · synced Jul 28, 2026