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L-Type HDL-C Reagent 1
EUDAMEDClass B (EU MDR)
Ref 999-73391Model 999-73391, 995-73491, 993-73291
Identity
- Trade Name
- L-Type HDL-C Reagent 1 EUDAMED
- Device Name
- L-Type HDL-C Reagent 1, L-Type HDL-C Reagent 2, HDL-C Calibrator EUDAMED
- Model / Reference
- 999-73391, 995-73491, 993-73291 EUDAMED999-73391 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14987481165028 EUDAMED
- Basic UDI-DI
- 498748114987481165028Z3 EUDAMED
- EMDN Code
- W01010215 HIGH DENSITY LIPOPROTEIN CHOLESTEROL 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 HDL-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 | 498748114987481165028Z3 | 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 2f33bcd0-70af-4cf1-9ade-6213419515d8 61 fields · synced May 25, 2026