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L-Type LDL-C Reagent 1
EUDAMEDClass B (EU MDR)
Ref 994-24991Model 994-24991, 994-25091, 998-24891
Identity
- Trade Name
- L-Type LDL-C Reagent 1 EUDAMED
- Device Name
- L-Type LDL-C Reagent 1, L-Type LDL-C Reagent 2, LDL-C Calibrator EUDAMED
- Model / Reference
- 994-24991, 994-25091, 998-24891 EUDAMED994-24991 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14987481165066 EUDAMED
- Basic UDI-DI
- 498748114987481165066ZB EUDAMED
- EMDN Code
- W01010221 LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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 LDL-C Reagent 1 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 | 498748114987481165066ZB | 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 764e9916-6f71-45db-853b-248174e13372 61 fields · synced Jun 19, 2026