Identity
- Trade Name
- Capillary adapter YZ-011B9 EUDAMED
- Device Name
- AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES EUDAMED
- Model / Reference
- YZ-011B9 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04931921041994 EUDAMED
- Basic UDI-DI
- 4931921IVD0021NR EUDAMED
- EMDN Code
- W0202010285 LIMITED PANEL CELL COUNTING ANALYSERS - CONSUMABLES 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Capillary adapter YZ-011B9 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 | 4931921IVD0021NR | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nihon Kohden Corporation
- EUDAMED SRN
- JP-MF-000019022
- Authorised Representative
- NIHON KOHDEN EUROPE GmbH DE-AR-000010740
Sources (1)
- EUDAMED 16deb0e2-8a26-45a9-8833-2d65ca5d142d 61 fields · synced Jul 27, 2026