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Hematology Analyzer Reagent Kit (Diluent and Lyse)
EUDAMEDClass A (EU MDR)
Ref PO-0017-01Model PTD-1:25 tests/kitRef 12.02.0822AModel PTD-1:25 tests/kit、PTD-1:50 tests/kit
Identity
- Trade Name
- Hematology Analyzer Reagent Kit (Diluent and Lyse) EUDAMED
- Device Name
- Hematology Analyzer Reagent Kit (Diluent and Lyse) EUDAMED
- Model / Reference
- PTD-1:25 tests/kit EUDAMEDPO-0017-01 EUDAMEDPTD-1:25 tests/kit、PTD-1:50 tests/kit EUDAMED12.02.0822A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970493092889 EUDAMED
- Basic UDI-DI
- 6970493090801016PA EUDAMED
- Direct Marketing DI
- 06970493092889 EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Hematology Analyzer Reagent Kit (Diluent and Lyse) by Shenzhen Dymind Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6970493090801016PA | Class A | 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 (2)
- EUDAMED 93740ca9-ffae-4bbf-b36c-e3daf9348260 61 fields · synced Jun 19, 2026
- EUDAMED 78087247-6f07-4a83-af7e-5b5160ec36e7 61 fields · synced Jun 19, 2026