Is this your brand? Sign in to claim ownership.

FUJIFILM WAKO PURE CHEMICAL CORPORATION

Japan·JP-MF-000013944

Last updated May 27, 2026

What FUJIFILM WAKO PURE CHEMICAL CORPORATION makes

The company manufactures in vitro diagnostic (IVD) reagents, calibrators, controls, and kits for laboratory testing, including products for measuring high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, non-esterified fatty acids, total complement activity (CH50), and albumin. These items are designed for use in clinical chemistry analyzers, nephelometry, and turbidimetry systems, supporting diagnostic assessments of lipid profiles, metabolic markers, and immune function.

The portfolio includes devices classified as Class A, B, C, I, and II under regulatory frameworks, with listings in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. The company is based in Japan and adheres to international regulatory standards for IVD products, ensuring compliance with global market requirements.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Japan
Address: 1-2, Doshomachi 3-Chome, Chuo-ku, Osaka, Japan
Website: fujifilm.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 877-714-1924
PRRC Contact: Tsuyoshi Okamoto
EUDAMED SRN: JP-MF-000013944
FDA FEI Number: —
DUNS Number: 690598875

Catalogue (88)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
L-Type LDL-C Reagent 2	994-25091	EUDAMED	Class B	Active
LDL-C Calibrator	998-24891	EUDAMED	Class B	Active
Aluminum Cap	995-04901	EUDAMED	Class A	Active
HA Control Set	991-81301	EUDAMED	Class B	Active
μTASWako AFP-L3 Sample Dilution Buffer	997-61501	EUDAMEDFDA UDI	Class A	Active
μTASWako DCP Control L	995-61301	EUDAMEDFDA UDI	Class C	Active
L-Type HDL-C Reagent 2	995-73491	EUDAMED	Class B	Active
μTASWako Chip Cassette	993-61601	EUDAMEDFDA UDI	Class A	Active
Complement Control Set	993-44001	EUDAMED	Class B	Active
β-Glucan Test R2: LAL Reagent	997-04101	EUDAMED	Class C	Active
CH50 Calibrator Set	993-43901	EUDAMED	Class B	Active
Hyaluronic acid-LT Set	999-81101	EUDAMED	Class B	Active
NEFA Standard	991-91791	EUDAMED	Class B	Active
NEFA-HR(2) R1 Set	994-91801	EUDAMED	Class B	Active
Hyaluronic acid-LT Set	993-81001	EUDAMED	Class B	Active
L-Type HDL-C Reagent 1	999-73391	EUDAMED	Class B	Active
β-Glucan Sample Diluent	999-04301	EUDAMED	Class A	Active
NEFA-HR(2) R2 Set	990-91901	EUDAMED	Class B	Active
HDL-C Calibrator	993-73291	EUDAMED	Class B	Active
BC Tip EXT	995-05001	EUDAMED	Class A	Active
L-Type LDL-C Reagent 1	994-24991	EUDAMED	Class B	Active
L-Type Total Bilirubin Reagent 2	998-24391	EUDAMED	Class B	Active
Autokit CH50 Set	993-40601	EUDAMED	Class B	Active
HA Calibrator Set	995-81201	EUDAMED	Class B	Active
Autokit CH50 Set	999-40701	EUDAMED	Class B	Active
μTASWako DCP	995-60701	EUDAMEDFDA UDI	Class C	Active
β-Glucan Test R1: Pretreatment Solution	993-04201	EUDAMED	Class C	Active
L-Type Direct Bilirubin Reagent 1	990-24091	EUDAMED	Class B	Active
μTASWako DCP Control H	991-61401	EUDAMEDFDA UDI	Class C	Active
LAL Control	995-04401	EUDAMED	Class C	Active
Autokit Total Ketone Bodies R2 Set	992-73401	EUDAMED	Class B	Active
Ketone Body Calibrator 300	993-73791	EUDAMED	Class B	Active
μTASWako Wash Solution	991-60801	EUDAMEDFDA UDI	Class A	Active
L-Type Direct Bilirubin Reagent 2	996-24191	EUDAMED	Class B	Active
μTASWako AFP-L3 Control L	997-61001	EUDAMEDFDA UDI	Class C	Active
Autokit Total Ketone Bodies R1 Set	996-73301	EUDAMED	Class B	Active
Autokit 3-HB R2 Set	994-73601	EUDAMED	Class B	Active
Autokit 3-HB R1 Set	998-73501	EUDAMED	Class B	Active

Related Companies

Authorised Representatives

FUJIFILM Wako Chemicals Europe GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.