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BioHermes Blood Glucose Control Solution
FDA UDIEUDAMEDRef GLU-C12Model GLU-GE C01
Identity
- Trade Name
- BioHermes Blood Glucose Control Solution FDA UDI
- Generic Name
- Glucose IVD, kit, electrometry FDA UDI
- Device Name
- Blood Glucose Control Solution EUDAMEDBlood Glucose Control Solution Intended use: The blood glucose control solution is intended to be used with corresponding blood glucose test strips and blood glucose meter as well as blood glucose and glycohemoglobin analyzer manufactured by Wuxi BioHermes Bio&Medical Technology Co., Ltd. Contents: 1x2mL Control L, 1x2mL Control N, 1x2mL Control H. FDA UDI
- Model / Reference
- GLU-GE C01 EUDAMEDFDA UDIGLU-C12 EUDAMED
- Description
- Blood Glucose Control Solution Intended use: The blood glucose control solution is intended to be used with corresponding blood glucose test strips and blood glucose meter as well as blood glucose and glycohemoglobin analyzer manufactured by Wuxi BioHermes Bio&Medical Technology Co., Ltd. Contents: 1x2mL Control L, 1x2mL Control N, 1x2mL Control H. FDA UDI
Identifiers
- Catalog Number
- GLU-C12 FDA UDI
- Primary DI / UDI-DI
- 06935784450106 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06935784450106 EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS 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
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
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 Blood Glucose Control Solution 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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- FORA — FORA CARE INC. · Class II
- OneTouch Ultra — Lifescan, Inc. · Class II
- 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 (2)
- FDA UDI 1ade8dcf-f0f3-4eea-ae0f-bfb3ce584310 34 fields · synced Jul 18, 2026
- EUDAMED 8c565bd5-5569-4a5b-9a36-888d31bc79d1 61 fields · synced Jul 18, 2026