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Auto Immuno Hematology Analzyer
EUDAMEDClass IVD General (EU MDR)
Ref PO-0015-04Model DP-H23Ref PO-0015-01Model DP-H21Ref PO-0015-03Model DP-H20
Identity
- Trade Name
- Auto Immuno Hematology Analzyer EUDAMEDAuto Immuno Hematology Analyzer EUDAMED
- Device Name
- Auto Immuno Hematology Analzyer EUDAMEDAuto Immuno Hematology Analyzer EUDAMED
- Model / Reference
- DP-H23 EUDAMEDPO-0015-04 EUDAMEDDP-H21 EUDAMEDPO-0015-01 EUDAMEDDP-H20 EUDAMEDPO-0015-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377300109 EUDAMED06941377300086 EUDAMED06941377301717 EUDAMED
- Basic UDI-DI
- B-06941377300109 EUDAMEDB-06941377300086 EUDAMEDB-06941377301717 EUDAMED
- EMDN Code
- W0202010299 LIMITED PANEL CELL COUNTING ANALYSERS - OTHER EUDAMEDW02020601 RAPID TEST CELL COUNT INSTRUMENTS 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 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-06941377300109 | 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 (3)
- EUDAMED 6d8df825-e57a-45cf-9ea4-45eb0307bef6 61 fields · synced Oct 6, 2026
- EUDAMED 60ba82db-62d1-4602-ab31-0078b079a63d 61 fields · synced May 17, 2026
- EUDAMED 8c2858d9-77bb-4f56-8d34-9b9a9cdddb16 61 fields · synced Jul 24, 2026