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A1cChek Express Glycohemoglobin Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref A1C-S42Model A1C-EXP S01
Identity
- Device Name
- A1cChek Express Glycohemoglobin Test Kit EUDAMED
- Model / Reference
- A1C-EXP S01 EUDAMEDA1C-S42 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26935784411170 EUDAMED
- Basic UDI-DI
- B-26935784411170 EUDAMED
- EMDN Code
- W0101060107 HBA1C TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
A1cChek Express Glycohemoglobin Test Kit by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-26935784411170 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuxi Biohermes Bio & Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014455
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED e09ec2b3-c1b5-4acd-9b00-0c50990b6743 61 fields · synced Jul 8, 2026