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Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)
EUDAMEDClass IVD General (EU MDR)
Ref R1:30mL×1 R2:10mL×1（704）
Identity
- Trade Name
- Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric) EUDAMED
- Device Name
- Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric) EUDAMED
- Model / Reference
- R1:30mL×1 R2:10mL×1（704） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674869405 EUDAMED
- Basic UDI-DI
- B-06971674869405 EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD — listed in…
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-06971674869405 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 3cc76dd5-2898-4063-b231-06d73df7e24c 61 fields · synced Jun 19, 2026