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NEFA-HR(2) R1 Set

EUDAMED

Class B (EU MDR)

Ref 994-91801Model 994-91801, 990-91901, 991-91791

by FUJIFILM Wako Pure Chemical Corporation

Identity

Trade Name
NEFA-HR(2) R1 Set EUDAMED
Device Name
NEFA-HR(2) R1 Set, NEFA-HR(2) R2 Set, NEFA Standard EUDAMED
Model / Reference
994-91801, 990-91901, 991-91791 EUDAMED
994-91801 EUDAMED

Identifiers

Primary DI / UDI-DI
04987481165120 EUDAMED
Basic UDI-DI
49874814987481165120TX EUDAMED
EMDN Code
W01010222 NON ESTERIFIED FATTY ACIDS EUDAMED

Classification

Device Class
Class B EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

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

Category: Low density lipoprotein (LDL) cholesterol IVD, reagent

NEFA-HR(2) R1 Set by Fujifilm Wako Pure Chemical Corporation — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Low density lipoprotein (LDL) cholesterol IVD, reagent.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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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 9a1a68b6-8441-4fb1-95c0-e6cfb56c3977 61 fields · synced Aug 3, 2026