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BioHermes GluCoA1c Blood Glucose Test Strips
FDA UDIEUDAMEDRef GLU-S32Model GLU-A1C S06
Identity
- Trade Name
- BioHermes GluCoA1c Blood Glucose Test Strips FDA UDI
- Generic Name
- Glucose IVD, kit, electrometry FDA UDI
- Device Name
- GluCoA1c Blood Glucose Test Strips EUDAMEDGluCoA1c Blood Glucose Test Strips, 50 Tests/Kit. Intended use: The GluCoA1c blood glucose test strips are for use with the GluCoA1c analyzer to quantitatively measure the glucose level of fresh capillary whole blood. Contents: 50 test strips; package insert. FDA UDIGluCoA1c Blood Glucose Test Strips, 50 Tests/Kit. Intended use: The GluCoA1c blood glucose test strips are for use with the GluCoA1c analyzer to quantitatively measure the glucose level of fresh capillary whole blood. Contents: 50 test strips; package insert. FDA UDI
- Model / Reference
- GLU-A1C S06 EUDAMEDFDA UDIGLU-S32 EUDAMEDGLU-A1C S04 FDA UDI
- Description
- GluCoA1c Blood Glucose Test Strips, 50 Tests/Kit. Intended use: The GluCoA1c blood glucose test strips are for use with the GluCoA1c analyzer to quantitatively measure the glucose level of fresh capillary whole blood. Contents: 50 test strips; package insert. FDA UDIGluCoA1c Blood Glucose Test Strips, 50 Tests/Kit. Intended use: The GluCoA1c blood glucose test strips are for use with the GluCoA1c analyzer to quantitatively measure the glucose level of fresh capillary whole blood. Contents: 50 test strips; package insert. FDA UDI
Identifiers
- Catalog Number
- GLU-S22 FDA UDIGLU-S32 FDA UDI
- Primary DI / UDI-DI
- 06935784420055 EUDAMEDFDA UDI06935784400057 FDA UDI
- Basic UDI-DI
- B-06935784420055 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
- GMDN Term
- Glucose IVD, kit, electrometry 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
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: Glucose IVD, kit, electrometry
BioHermes GluCoA1c Blood Glucose Test Strips by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Glucose IVD, kit, electrometry.
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- EasyMax 15 Blood Glucose Test Strip — EPS BIO TECHNOLOGY CORP. · Class II
- Tyson Bio 50H Blood Glucose Test Strip, 25T — TYSON BIORESEARCH INC. · Class II
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 (3)
- FDA UDI fc297b54-f51c-47f7-963e-327e15d3c5ac 34 fields · synced Jul 21, 2026
- FDA UDI c474aa04-32ef-42f8-97c8-44f0cbbb88f6 34 fields · synced May 30, 2026
- EUDAMED d7ea1d40-4b49-4491-a46a-3b4e53caacfa 61 fields · synced Jul 21, 2026