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L-Type Direct Bilirubin Reagent 2
EUDAMEDClass B (EU MDR)
Ref 996-24191Model 990-24091, 996-24191
Identity
- Trade Name
- L-Type Direct Bilirubin Reagent 2 EUDAMED
- Device Name
- L-Type Direct Bilirubin Reagent 1, L-Type Direct Bilirubin Reagent 2 EUDAMED
- Model / Reference
- 990-24091, 996-24191 EUDAMED996-24191 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14987481164908 EUDAMED
- Basic UDI-DI
- 4987481149874811648922G EUDAMED
- EMDN Code
- W01010203 BILIRUBIN EUDAMED
Classification
- Device Class
- Class B 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
L-Type Direct Bilirubin Reagent 2 by Fujifilm Wako Pure Chemical Corporation — Class B — 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 | 4987481149874811648922G | Class B | 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 6d4b0380-8a99-441e-ad23-78a9117d8642 61 fields · synced Oct 6, 2026