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Hematology Analyzer Reagent Kit
EUDAMEDClass A (EU MDR)
Ref PO-0004-01Model PTD-103 25 tests/kitModel PTD-103 25 test/kit
Identity
- Trade Name
- Hematology Analyzer Reagent Kit EUDAMED
- Device Name
- Hematology Analyzer Reagent Kit EUDAMED
- Model / Reference
- PTD-103 25 tests/kit EUDAMEDPO-0004-01 EUDAMEDPTD-103 25 test/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377300345 EUDAMED
- Basic UDI-DI
- 697611745W010300000018H EUDAMED
- Direct Marketing DI
- 06941377300345 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
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Hematology Analyzer Reagent Kit by Shenzhen Dymind Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697611745W010300000018H | 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 00eead2d-395a-4ffa-b4a0-9e36469d2720 61 fields · synced Jul 9, 2026
- EUDAMED 017bad56-41ed-4430-98aa-26def3df07b8 61 fields · synced Jul 9, 2026