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Auto Hematology Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref XQ-0110-02Model DH-850Ref XQ-0004-04Model DF50CRPRef XQ-0076-01Model DH36XRef XQ-0059-03 Model DH-85Ref XQ-0081-06Model D7-CRPRef XQ-0079-01Model DM79XRef XQ-0075-06Model DH-615Ref XQ-0001-01Model DH31Ref XQ-0110-09Model DH-850CSRef XQ-0002-04Model DF55Ref XQ-0056-06Model DH26Ref XQ-0056-02Model DH22Ref XQ-0077-01Model UN73Ref XQ-0110-03Model DH-860Ref XQ-0059-05Model DH-88CSRef XQ-0110-12Model DH-860CSRef DMP101DP-H10Model DP-H10Ref XQ-0056-03Model DH21Ref XQ-0110-05Model DH-820CRPRef XQ-0004-06Model DF53CRPRef XQ-0042-02Model DH-800[T7]CRPRef XQ-0042-03Model DH-800[T8]CRPRef XQ-0042-08Model DH-800[H7]Ref XQ-0004-02Model DF3-CRPRef XQ-0002-03Model DF53Ref XQ-0003-02Model DH73Ref XQ-0112-01Model EH360Ref XQ-0042-05Model DH-800[T7]CSRef XQ-0056-05Model DH25Ref XQ-0004-05Model DF52CRPRef XQ-0004-03Model DF5-CRP
Identity
- Trade Name
- Auto Hematology Analyzer EUDAMED
- Device Name
- Auto Hematology Analyzer EUDAMED
- Model / Reference
- DH-850 EUDAMEDXQ-0110-02 EUDAMEDDF50CRP EUDAMEDXQ-0004-04 EUDAMEDDH36X EUDAMEDXQ-0076-01 EUDAMEDDH-85 EUDAMEDXQ-0059-03 EUDAMEDD7-CRP EUDAMEDXQ-0081-06 EUDAMEDDM79X EUDAMEDXQ-0079-01 EUDAMEDDH-615 EUDAMEDXQ-0075-06 EUDAMEDDH31 EUDAMEDXQ-0001-01 EUDAMEDDH-850CS EUDAMEDXQ-0110-09 EUDAMEDDF55 EUDAMEDXQ-0002-04 EUDAMEDDH26 EUDAMEDXQ-0056-06 EUDAMEDDH22 EUDAMEDXQ-0056-02 EUDAMEDUN73 EUDAMEDXQ-0077-01 EUDAMEDDH-860 EUDAMEDXQ-0110-03 EUDAMEDDH-88CS EUDAMEDXQ-0059-05 EUDAMEDDH-860CS EUDAMEDXQ-0110-12 EUDAMEDDP-H10 EUDAMEDDMP101DP-H10 EUDAMEDDH21 EUDAMEDXQ-0056-03 EUDAMEDDH-820CRP EUDAMEDXQ-0110-05 EUDAMEDDF53CRP EUDAMEDXQ-0004-06 EUDAMEDDH-800[T7]CRP EUDAMEDXQ-0042-02 EUDAMEDDH-800[T8]CRP EUDAMEDXQ-0042-03 EUDAMEDDH-800[H7] EUDAMEDXQ-0042-08 EUDAMEDDF3-CRP EUDAMEDXQ-0004-02 EUDAMEDDF53 EUDAMEDXQ-0002-03 EUDAMEDDH73 EUDAMEDXQ-0003-02 EUDAMEDEH360 EUDAMEDXQ-0112-01 EUDAMEDDH-800[T7]CS EUDAMEDXQ-0042-05 EUDAMEDDH25 EUDAMEDXQ-0056-05 EUDAMEDDF52CRP EUDAMEDXQ-0004-05 EUDAMEDDF5-CRP EUDAMEDXQ-0004-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377306064 EUDAMED06976117452251 EUDAMED06976117450301 EUDAMED06941377303483 EUDAMED06970493096818 EUDAMED06976117452268 EUDAMED06970493092735 EUDAMED06970493097143 EUDAMED06941377306125 EUDAMED06970493091042 EUDAMED06970493090670 EUDAMED06970493090960 EUDAMED06976117452206 EUDAMED06941377306071 EUDAMED06941377303506 EUDAMED06941377306149 EUDAMED06970493092926 EUDAMED06970493090953 EUDAMED06941377306095 EUDAMED06976117457768 EUDAMED06941377302561 EUDAMED06941377302578 EUDAMED06976117451889 EUDAMED06976117457331 EUDAMED06970493091035 EUDAMED06970493091073 EUDAMED06976117452718 EUDAMED06976117452688 EUDAMED06970493090984 EUDAMED06976117457591 EUDAMED06976117457362 EUDAMED
- Basic UDI-DI
- B-06941377306064 EUDAMEDB-06976117452251 EUDAMEDB-06976117450301 EUDAMEDB-06941377303483 EUDAMEDB-06970493096818 EUDAMEDB-06976117452268 EUDAMEDB-06970493092735 EUDAMEDB-06970493097143 EUDAMEDB-06941377306125 EUDAMEDB-06970493091042 EUDAMEDB-06970493090670 EUDAMEDB-06970493090960 EUDAMEDB-06976117452206 EUDAMEDB-06941377306071 EUDAMEDB-06941377303506 EUDAMEDB-06941377306149 EUDAMEDB-06970493092926 EUDAMEDB-06970493090953 EUDAMEDB-06941377306095 EUDAMEDB-06976117457768 EUDAMEDB-06941377302561 EUDAMEDB-06941377302578 EUDAMEDB-06976117451889 EUDAMEDB-06976117457331 EUDAMEDB-06970493091035 EUDAMEDB-06970493091073 EUDAMEDB-06976117452718 EUDAMEDB-06976117452688 EUDAMEDB-06970493090984 EUDAMEDB-06976117457591 EUDAMEDB-06976117457362 EUDAMED
- EMDN Code
- W0202010201 AUTOMATED 3 PART HEMATOLOGY ANALYSERS EUDAMEDW0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMEDW0103010503 MULTILEVEL BLOOD CONTROLS EUDAMEDW0202010101,W0202010201 EUDAMEDW0202010103 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - HIGH ROUTINE (Throughput > 120 samples/hr) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
EUDAMEDEUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Auto Hematology Analyzer 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-06941377306064 | 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 (31)
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- EUDAMED 81bc94a2-abae-47af-ba6f-b56f7e69a510 61 fields · synced May 16, 2026
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- EUDAMED cb27ea5b-dbc5-4bba-8157-5040df328804 61 fields · synced May 18, 2026
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- EUDAMED c4371b75-b8ad-4cbb-86d5-15fb049ed991 61 fields · synced May 18, 2026
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- EUDAMED e69afa49-9daa-48f4-98bd-af1ce12908ae 61 fields · synced May 18, 2026
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- EUDAMED e13728e8-3bb9-4111-a442-f0a973eaaac4 61 fields · synced May 19, 2026
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- EUDAMED 72920deb-8829-43f6-922b-9381a050cdb0 61 fields · synced Jul 9, 2026
- EUDAMED 9a460191-64cc-4a81-aa45-ce2498974dff 61 fields · synced Jul 10, 2026
- EUDAMED 02198242-df4a-4e11-bf05-ce3020470137 61 fields · synced Jul 10, 2026
- EUDAMED 33b3d536-23fc-41a0-b7e7-014da82931a6 61 fields · synced Jul 14, 2026
- EUDAMED 8eeda826-c5dc-45c6-a03e-cf818275b20d 61 fields · synced Jul 18, 2026
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- EUDAMED d6be280b-c2d8-4b9e-bd7a-49eb420021ec 61 fields · synced Aug 1, 2026
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- EUDAMED 9a4961a6-8c96-460e-aa74-508ef0ee0fe6 61 fields · synced Aug 4, 2026