Identity
- Trade Name
- ISOTONAC･3 MEK-640 EUDAMED
- Device Name
- CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS) EUDAMED
- Model / Reference
- T436D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04931921800881 EUDAMED
- Basic UDI-DI
- 4931921IVD0016NY 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
Isotonac･3 Mek-640 by Nihon Kohden Corporation — 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 | 4931921IVD0016NY | Class A | Active |
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Manufacturer
- Manufacturer
- Nihon Kohden Corporation
- EUDAMED SRN
- JP-MF-000019022
- Authorised Representative
- NIHON KOHDEN EUROPE GmbH DE-AR-000010740
Sources (1)
- EUDAMED 0c288d5d-03f3-447d-bbd9-6ad0bac58018 61 fields · synced Jul 11, 2026