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β-Glucan Test R2: LAL Reagent
EUDAMEDClass C (EU MDR)
Ref 997-04101Model 993-04201, 997-04101, 995-04401
Identity
- Trade Name
- β-Glucan Test R2: LAL Reagent EUDAMED
- Device Name
- β-Glucan Test R1: Pretreatment Solution, β-Glucan Test R2: LAL Reagent, LAL Control EUDAMED
- Model / Reference
- 993-04201, 997-04101, 995-04401 EUDAMED997-04101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14987481163796 EUDAMED
- Basic UDI-DI
- 498748114987481163802ZB EUDAMED
- EMDN Code
- W0105060399 MYCOLOGY IMMUNOASSAYS - OTHER EUDAMEDW0105060304 BETA-D-GLUCAN (PAN-FUNGAL MARKERS) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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 Test R2: LAL Reagent by Fujifilm Wako Pure Chemical Corporation — Class C — 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 | 498748114987481163802ZB | Class C | 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 (2)
- EUDAMED bd4655bf-bff2-4929-b89c-212f23efecc6 61 fields · synced Oct 6, 2026
- EUDAMED ecc7b62e-47e6-49b1-82e5-e18ebf2c7bbb 61 fields · synced Jul 16, 2026