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Auto Bio-Immuno Hematology Analzyer
EUDAMEDClass IVD General (EU MDR)
Ref PO-0015-05Model DP-H20 PlusRef PO-0015-03Model DP-H20Ref PO-0015-07Model DP-H22 Plus
Identity
- Trade Name
- Auto Bio-Immuno Hematology Analzyer EUDAMEDAuto Immuno Hematology Analzyer EUDAMEDAuto Bio-immuno Hematology Analyzer EUDAMED
- Device Name
- Auto Bio-Immuno Hematology Analzyer EUDAMEDAuto Immuno Hematology Analzyer EUDAMEDAuto Bio-immuno Hematology Analyzer EUDAMED
- Model / Reference
- DP-H20 Plus EUDAMEDPO-0015-05 EUDAMEDDP-H20 EUDAMEDPO-0015-03 EUDAMEDDP-H22 Plus EUDAMEDPO-0015-07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377300031 EUDAMED06941377300079 EUDAMED06941377300055 EUDAMED06941377306170 EUDAMED
- Basic UDI-DI
- B-06941377300031 EUDAMEDB-06941377300079 EUDAMEDB-06941377300055 EUDAMEDB-06941377306170 EUDAMED
- EMDN Code
- W0202010299 LIMITED PANEL CELL COUNTING ANALYSERS - OTHER EUDAMEDW02010399 INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Auto Bio-Immuno Hematology Analzyer 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-06941377300031 | 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 (4)
- EUDAMED 82c1db60-56b6-499b-bcc8-3872a1bb1f34 61 fields · synced Oct 6, 2026
- EUDAMED 15c5be8a-5fb7-4d77-a7ef-98f7d9c92f4f 61 fields · synced May 17, 2026
- EUDAMED 92628f2a-db07-4964-8842-36209c33a75e 61 fields · synced May 17, 2026
- EUDAMED 8e531780-e4f2-4e42-ae11-ccb29a6ee319 61 fields · synced Aug 2, 2026