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HbA1c Calibrator
EUDAMEDClass IVD General (EU MDR)
Ref XQ-0106-01Model A1c-CAL：2x0.5mLRef XQ-0106-02Model A1c-CAL 2×1.0 mL（A1c-CAL1, A1c-CAL2）
Identity
- Trade Name
- HbA1c Calibrator EUDAMED
- Device Name
- HbA1c Calibrator EUDAMED
- Model / Reference
- A1c-CAL：2x0.5mL EUDAMEDXQ-0106-01 EUDAMEDA1c-CAL 2×1.0 mL（A1c-CAL1, A1c-CAL2） EUDAMEDXQ-0106-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377305845 EUDAMED06941377305852 EUDAMED
- Basic UDI-DI
- B-06941377305845 EUDAMEDB-06941377305852 EUDAMED
- EMDN Code
- W0101050205 DIABETES CONTROLS EUDAMEDW0103010507 WHOLE BLOOD CALIBRATORS 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 Calibrator 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-06941377305845 | 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 be045b4d-c5f9-4050-962b-23cea78c7bfe 61 fields · synced Oct 6, 2026
- EUDAMED b1f7aeb1-a030-47ba-8fe9-3fd953bc6d80 61 fields · synced Jul 17, 2026