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Sample Diluent
EUDAMEDClass A (EU MDR)
Ref PO-0024-02Model PTD-A 400μL×50Ref 12.02.0804A
Identity
- Trade Name
- Sample Diluent EUDAMED
- Device Name
- Sample Diluent EUDAMED
- Model / Reference
- PTD-A 400μL×50 EUDAMEDPO-0024-02 EUDAMED12.02.0804A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117453265 EUDAMED
- Basic UDI-DI
- 6970493090801018PE EUDAMED
- Direct Marketing DI
- 06976117453265 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Sample Diluent 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 | 6970493090801018PE | 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 86efc6a1-8651-401f-88b3-cf71d39be03a 61 fields · synced Jun 18, 2026
- EUDAMED 242c6100-9f79-493d-b174-4cb5f4826a80 61 fields · synced Jun 18, 2026