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Hematology Control
EUDAMEDClass IVD General (EU MDR)
Ref /Model Model：CH-5QC，High value(H):3mL×3Model Model：CH-5QC，Low value(L):3mL×3Model Model：CH-5QC，Low value(L):3mL×1Model Model：CH-5QC，Normal value (N):3mL×2Model Model：CH-5QC，Normal value (N):3mL×3
Identity
- Trade Name
- Hematology Control EUDAMED
- Device Name
- Hematology Control EUDAMED
- Model / Reference
- Model：CH-5QC，High value(H):3mL×3 EUDAMED/ EUDAMEDModel：CH-5QC，Low value(L):3mL×3 EUDAMEDModel：CH-5QC，Low value(L):3mL×1 EUDAMEDModel：CH-5QC，Normal value (N):3mL×2 EUDAMEDModel：CH-5QC，Normal value (N):3mL×3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429026542 EUDAMED06945429026603 EUDAMED06945429026580 EUDAMED06945429026566 EUDAMED06945429026573 EUDAMED
- Basic UDI-DI
- B-06945429026542 EUDAMEDB-06945429026603 EUDAMEDB-06945429026580 EUDAMEDB-06945429026566 EUDAMEDB-06945429026573 EUDAMED
- EMDN Code
- W0103010502 ABNORMAL BLOOD CONTROLS EUDAMEDW0103010501 NORMAL BLOOD CONTROLS 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 Control 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-06945429026542 | 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 (5)
- EUDAMED e159e8a9-f07d-46dd-8f3f-c0358f8ac8ba 61 fields · synced Oct 6, 2026
- EUDAMED b1e60d6a-179c-486a-a6da-afb3ff8ff8df 61 fields · synced May 16, 2026
- EUDAMED a136c9b0-394a-4447-81b0-9a9d0bd76e17 61 fields · synced May 18, 2026
- EUDAMED b3fc87cf-6426-4737-af6f-967c2617da92 61 fields · synced May 19, 2026
- EUDAMED edd58b18-4ee3-4b77-9594-6e7f569511c8 61 fields · synced May 19, 2026