Identity
- Trade Name
- β-Glucan Sample Diluent EUDAMED
- Device Name
- β-Glucan Sample Diluent EUDAMED
- Model / Reference
- 999-04301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14987481163819 EUDAMED
- Basic UDI-DI
- 498748114987481163819ZU EUDAMED
- EMDN Code
- W0105900201 BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
β-Glucan Sample Diluent by Fujifilm Wako Pure Chemical 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 | 498748114987481163819ZU | Class A | Active |
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Manufacturer
- Manufacturer
- FUJIFILM Wako Pure Chemical Corporation
- EUDAMED SRN
- JP-MF-000013944
- Authorised Representative
- FUJIFILM Wako Chemicals Europe GmbH DE-AR-000011552
Sources (1)
- EUDAMED 451adb66-adb7-4a26-8964-c97a967d12bb 61 fields · synced Oct 6, 2026