← Back to catalogue
LAL Control
EUDAMEDClass C (EU MDR)
Ref 995-04401Model 993-04201, 997-04101, 995-04401
Identity
- Trade Name
- LAL Control 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 EUDAMED995-04401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987481163829 EUDAMED
- Basic UDI-DI
- 498748114987481163802ZB EUDAMED
- EMDN Code
- W0105080806 MYCOLOGY CONTROLS - INF.IMM. 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
LAL Control 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 |
Is this your device? Claim it to add documentation and request validation.
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 ad7195b6-6796-48ad-963f-49bd041dbd09 61 fields · synced Jun 17, 2026