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Hematology Calibrator
EUDAMEDClass IVD General (EU MDR)
Ref XQ-0068-01Model DM-CAL-5E：1*3mlRef XQ-0068-03Model DM-CAL-5E 3mL×3Ref XQ-0068-02Model DM-CAL-5E 3mL×2Ref XQ-0009-03Model DM-CAL-PFRef XQ-0006-02Model DM-CAL 3mL × 2Ref XQ-0008-03Model DM-CAL PLUS 3mL × 3Ref XQ-0008-02Model DM-CAL PLUS 3mL × 2Ref XQ-0006-03Model DM-CAL 3mL × 3
Identity
- Trade Name
- Hematology Calibrator EUDAMED
- Device Name
- Hematology Calibrator EUDAMED
- Model / Reference
- DM-CAL-5E：1*3ml EUDAMEDXQ-0068-01 EUDAMEDDM-CAL-5E 3mL×3 EUDAMEDXQ-0068-03 EUDAMEDDM-CAL-5E 3mL×2 EUDAMEDXQ-0068-02 EUDAMEDDM-CAL-PF EUDAMEDXQ-0009-03 EUDAMEDDM-CAL 3mL × 2 EUDAMEDXQ-0006-02 EUDAMEDDM-CAL PLUS 3mL × 3 EUDAMEDXQ-0008-03 EUDAMEDDM-CAL PLUS 3mL × 2 EUDAMEDXQ-0008-02 EUDAMEDDM-CAL 3mL × 3 EUDAMEDXQ-0006-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970493091998 EUDAMED06970493092629 EUDAMED06970493092612 EUDAMED06976117451919 EUDAMED06970493096405 EUDAMED06970493096542 EUDAMED06970493096535 EUDAMED06970493096412 EUDAMED
- Basic UDI-DI
- B-06970493091998 EUDAMEDB-06970493092629 EUDAMEDB-06970493092612 EUDAMED6970493090608031PV EUDAMEDB-06970493096405 EUDAMEDB-06970493096542 EUDAMEDB-06970493096535 EUDAMEDB-06970493096412 EUDAMED
- Direct Marketing DI
- 06976117451919 EUDAMED
- EMDN Code
- W0103010507 WHOLE BLOOD CALIBRATORS EUDAMEDW0103010599 HAEMATOLOGY CONTROLS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Hematology Calibrator by Shenzhen Dymind Biotechnology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06970493091998 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06970493091998 | 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 (8)
- EUDAMED 53456365-a363-4f47-9c32-e9b0e7d28fb9 61 fields · synced Oct 6, 2026
- EUDAMED a06502c7-fb6a-43ea-82b1-4517d44095a0 61 fields · synced Jul 9, 2026
- EUDAMED 1597651a-8308-4c6a-94cf-7fcbbeef89dd 61 fields · synced Jul 10, 2026
- EUDAMED fe95c343-1d08-43fc-9db0-b6759eeb3c72 61 fields · synced Jul 10, 2026
- EUDAMED 596fcf3a-7883-4c31-9e8e-5123b4ed8590 61 fields · synced Jul 14, 2026
- EUDAMED c2b3f8de-0983-43e9-93db-2403537e572e 61 fields · synced Jul 14, 2026
- EUDAMED 2f5f9432-7711-4c2b-a659-141499a7f9a0 61 fields · synced Jul 20, 2026
- EUDAMED ee3bd379-0264-4fbd-ba69-a481d697b612 61 fields · synced Jul 21, 2026