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Hematology Calibrator
EUDAMEDClass IVD General (EU MDR)
Ref Low value:6560-ER00001 Normal value:6560-ER00002 High value:6560-ER00003Model Model：CH-CAL，Specification:3mL×2Ref /Model Model：CH-CAL，Specification:3mL×3
Identity
- Trade Name
- Hematology Calibrator EUDAMED
- Device Name
- Hematology Calibrator EUDAMED
- Model / Reference
- Model：CH-CAL，Specification:3mL×2 EUDAMEDLow value:6560-ER00001 Normal value:6560-ER00002 High value:6560-ER00003 EUDAMEDModel：CH-CAL，Specification:3mL×3 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429026504 EUDAMED06945429026511 EUDAMED
- Basic UDI-DI
- B-06945429026504 EUDAMEDB-06945429026511 EUDAMED
- EMDN Code
- W0103010507 WHOLE BLOOD CALIBRATORS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Iceland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Hematology Calibrator by Shenzhen Comen Medical Instruments 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-06945429026504 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 4bc8603c-77ca-4bc4-8e7d-e38965cc625e 61 fields · synced Oct 6, 2026
- EUDAMED b947cef4-cb95-46d6-b9f0-8fce701d50d4 61 fields · synced May 19, 2026