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HbA1c Control Material
EUDAMEDClass IVD General (EU MDR)
Ref XQ-0107-01 Model A1c-QC：2x0.5 mLRef XQ-0107-02Model A1c-QC 2x1.0 mL（A1c-QC1、A1c-QC2）
Identity
- Trade Name
- HbA1c Control Material EUDAMED
- Device Name
- HbA1c Control Material EUDAMED
- Model / Reference
- A1c-QC：2x0.5 mL EUDAMEDXQ-0107-01 EUDAMEDA1c-QC 2x1.0 mL（A1c-QC1、A1c-QC2） EUDAMEDXQ-0107-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377305869 EUDAMED06941377305876 EUDAMED
- Basic UDI-DI
- B-06941377305869 EUDAMEDB-06941377305876 EUDAMED
- EMDN Code
- W0101050302 CALIBRATORS SINGLE COMPONENT (CC) EUDAMEDW0103010504 HAEMOGLOBIN CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
HbA1c Control Material by Shenzhen Dymind Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06941377305869 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dymind Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024842
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (2)
- EUDAMED 5389d377-29da-4270-893d-2d792d840991 61 fields · synced Oct 6, 2026
- EUDAMED 3760f477-2c58-4c79-91b4-56cd09935443 61 fields · synced Sep 18, 2026